Dermatology

TOPLINE:

Patients with alopecia areata (AA) had a higher prevalence of several psychiatric and autoimmune comorbidities at baseline and were at greater risk of developing those comorbidities after diagnosis.

METHODOLOGY:

• Researchers evaluated 63,384 patients with AA and 3,309,107 individuals without AA (aged 12-64 years) from the Merative MarketScan Research Databases.
• The matched cohorts included 16,512 patients with AA and 66,048 control individuals.
• Outcomes were the prevalence of psychiatric and autoimmune diseases at baseline and the incidence of new-onset psychiatric and autoimmune diseases during the year after diagnosis.

TAKEAWAY:

• Overall, patients with AA showed a greater prevalence of any psychiatric disease (30.9% vs 26.8%; P < .001) and any immune-mediated or autoimmune disease (16.1% vs 8.9%; P < .0001) than those with controls.
• In matched cohorts, patients with AA also showed a higher incidence of any new-onset psychiatric diseases (10.2% vs 6.8%; P < .001) or immune-mediated or autoimmune disease (6.2% vs 1.5%; P <.001) within the first 12 months of AA diagnosis than those with controls.
• Among patients with AA, the risk of developing a psychiatric comorbidity was higher (adjusted hazard ratio [aHR], 1.3; 95% CI, 1.3-1.4). The highest risks were seen for adjustment disorder (aHR, 1.5), panic disorder (aHR, 1.4), and sexual dysfunction (aHR, 1.4).
• Compared with controls, patients with AA were also at an increased risk of developing immune-mediated or autoimmune comorbidities (aHR, 2.7; 95% CI, 2.5-2.8), with the highest for systemic lupus (aHR, 5.7), atopic dermatitis (aHR, 4.3), and vitiligo (aHR, 3.8).

IN PRACTICE:

“Routine monitoring of patients with AA, especially those at risk of developing comorbidities, may permit earlier and more effective intervention,” the authors wrote.

SOURCE:

The study was led by Arash Mostaghimi, MD, MPA, MPH, Brigham and Women’s Hospital and Harvard University, Boston. It was published online on July 31, 2024, in JAMA Dermatology.

LIMITATIONS:

Causality could not be inferred because of the retrospective nature of the study. Comorbidities were solely diagnosed on the basis of diagnostic codes, and researchers did not have access to characteristics such as lab values that could have indicated any underlying comorbidity before the AA diagnosis. This study also did not account for the varying levels of severity of the disease, which may have led to an underestimation of disease burden and the risk for comorbidities.

DISCLOSURES:

AbbVie provided funding for this study. Mostaghimi disclosed receiving personal fees from Abbvie and several other companies outside of this work. The other four authors were current or former employees of Abbvie and have or may have stock and/or stock options in AbbVie.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients with alopecia areata (AA) had a higher prevalence of several psychiatric and autoimmune comorbidities at baseline and were at greater risk of developing those comorbidities after diagnosis.

METHODOLOGY:

• Researchers evaluated 63,384 patients with AA and 3,309,107 individuals without AA (aged 12-64 years) from the Merative MarketScan Research Databases.
• The matched cohorts included 16,512 patients with AA and 66,048 control individuals.
• Outcomes were the prevalence of psychiatric and autoimmune diseases at baseline and the incidence of new-onset psychiatric and autoimmune diseases during the year after diagnosis.

TAKEAWAY:

• Overall, patients with AA showed a greater prevalence of any psychiatric disease (30.9% vs 26.8%; P < .001) and any immune-mediated or autoimmune disease (16.1% vs 8.9%; P < .0001) than those with controls.
• In matched cohorts, patients with AA also showed a higher incidence of any new-onset psychiatric diseases (10.2% vs 6.8%; P < .001) or immune-mediated or autoimmune disease (6.2% vs 1.5%; P <.001) within the first 12 months of AA diagnosis than those with controls.
• Among patients with AA, the risk of developing a psychiatric comorbidity was higher (adjusted hazard ratio [aHR], 1.3; 95% CI, 1.3-1.4). The highest risks were seen for adjustment disorder (aHR, 1.5), panic disorder (aHR, 1.4), and sexual dysfunction (aHR, 1.4).
• Compared with controls, patients with AA were also at an increased risk of developing immune-mediated or autoimmune comorbidities (aHR, 2.7; 95% CI, 2.5-2.8), with the highest for systemic lupus (aHR, 5.7), atopic dermatitis (aHR, 4.3), and vitiligo (aHR, 3.8).

IN PRACTICE:

“Routine monitoring of patients with AA, especially those at risk of developing comorbidities, may permit earlier and more effective intervention,” the authors wrote.

SOURCE:

The study was led by Arash Mostaghimi, MD, MPA, MPH, Brigham and Women’s Hospital and Harvard University, Boston. It was published online on July 31, 2024, in JAMA Dermatology.

LIMITATIONS:

Causality could not be inferred because of the retrospective nature of the study. Comorbidities were solely diagnosed on the basis of diagnostic codes, and researchers did not have access to characteristics such as lab values that could have indicated any underlying comorbidity before the AA diagnosis. This study also did not account for the varying levels of severity of the disease, which may have led to an underestimation of disease burden and the risk for comorbidities.

DISCLOSURES:

AbbVie provided funding for this study. Mostaghimi disclosed receiving personal fees from Abbvie and several other companies outside of this work. The other four authors were current or former employees of Abbvie and have or may have stock and/or stock options in AbbVie.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients with alopecia areata (AA) had a higher prevalence of several psychiatric and autoimmune comorbidities at baseline and were at greater risk of developing those comorbidities after diagnosis.

METHODOLOGY:

• Researchers evaluated 63,384 patients with AA and 3,309,107 individuals without AA (aged 12-64 years) from the Merative MarketScan Research Databases.
• The matched cohorts included 16,512 patients with AA and 66,048 control individuals.
• Outcomes were the prevalence of psychiatric and autoimmune diseases at baseline and the incidence of new-onset psychiatric and autoimmune diseases during the year after diagnosis.

TAKEAWAY:

• Overall, patients with AA showed a greater prevalence of any psychiatric disease (30.9% vs 26.8%; P < .001) and any immune-mediated or autoimmune disease (16.1% vs 8.9%; P < .0001) than those with controls.
• In matched cohorts, patients with AA also showed a higher incidence of any new-onset psychiatric diseases (10.2% vs 6.8%; P < .001) or immune-mediated or autoimmune disease (6.2% vs 1.5%; P <.001) within the first 12 months of AA diagnosis than those with controls.
• Among patients with AA, the risk of developing a psychiatric comorbidity was higher (adjusted hazard ratio [aHR], 1.3; 95% CI, 1.3-1.4). The highest risks were seen for adjustment disorder (aHR, 1.5), panic disorder (aHR, 1.4), and sexual dysfunction (aHR, 1.4).
• Compared with controls, patients with AA were also at an increased risk of developing immune-mediated or autoimmune comorbidities (aHR, 2.7; 95% CI, 2.5-2.8), with the highest for systemic lupus (aHR, 5.7), atopic dermatitis (aHR, 4.3), and vitiligo (aHR, 3.8).

IN PRACTICE:

“Routine monitoring of patients with AA, especially those at risk of developing comorbidities, may permit earlier and more effective intervention,” the authors wrote.

SOURCE:

The study was led by Arash Mostaghimi, MD, MPA, MPH, Brigham and Women’s Hospital and Harvard University, Boston. It was published online on July 31, 2024, in JAMA Dermatology.

LIMITATIONS:

Causality could not be inferred because of the retrospective nature of the study. Comorbidities were solely diagnosed on the basis of diagnostic codes, and researchers did not have access to characteristics such as lab values that could have indicated any underlying comorbidity before the AA diagnosis. This study also did not account for the varying levels of severity of the disease, which may have led to an underestimation of disease burden and the risk for comorbidities.

DISCLOSURES:

AbbVie provided funding for this study. Mostaghimi disclosed receiving personal fees from Abbvie and several other companies outside of this work. The other four authors were current or former employees of Abbvie and have or may have stock and/or stock options in AbbVie.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Tirbanibulin ointment 1% shows good safety and tolerability in the treatment of actinic keratosis (AK) in fields of up to 100 cm2 on the face and scalp.

METHODOLOGY:

• This phase 3 multicenter, single-arm trial evaluated the safety and tolerability of tirbanibulin ointment 1% in 105 adults with 4-12 clinically typical, visible, and discrete AKs on the face or balding scalp from June to December 2022 in the United States. (In June 2024, the Food and Drug Administration approved a supplemental new drug application for tirbanibulin 1%, a microtubule inhibitor, allowing the expansion of the surface area treated for AKs of the face or scalp from 25 cm² to 100 cm².)
• Participants applied tirbanibulin ointment 1% once daily for 5 days over a treatment field of about 100 cm² on the face or balding scalp. A total of 102 patients completed the study.
• Safety and tolerability were evaluated with reports of treatment-emergent adverse events (TEAEs) and a composite score of six local tolerability signs on days 5, 8, 15, and 29, and on completion of the evaluation period on day 57.

TAKEAWAY:

• The most common local effects of treatment were erythema (96.1% of patients) and flaking or scaling (84.4%), with severe cases reported in 5.8% and 8.7% of the patients, respectively.
• The mean maximum local tolerability composite score was 4.1 out of 18, which peaked around day 8 and returned to baseline by day 29.
• TEAEs considered related to the treatment were reported in 18.1% of patients; the most frequent were application site pruritus (10.5%) and application site pain (8.6%). No adverse events led to the discontinuation of treatment.
• The mean percent reduction in the lesion count from baseline was 77.8% at day 57, with a mean lesion count of 1.8 at the end of the study.

IN PRACTICE:

In this study, “local tolerability and safety profiles were well characterized in patients with 4-12 clinically typical, visible, and discrete AK lesions in a field of 100 cm² and were consistent with those previously reported in patients with AK treated in pivotal trials with tirbanibulin over a smaller field (25 cm²),” the authors wrote.

SOURCE:

The study, led by Neal Bhatia, MD, of Therapeutics Clinical Research, San Diego, was published online in JAAD International.

LIMITATIONS:

The study was limited by the lack of a placebo group and the absence of long-term follow-up. 

DISCLOSURES:

This study was funded by Almirall. Five authors reported being employees of Almirall. Other authors declared having ties with various other sources, including Almirall.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Tirbanibulin ointment 1% shows good safety and tolerability in the treatment of actinic keratosis (AK) in fields of up to 100 cm2 on the face and scalp.

METHODOLOGY:

• This phase 3 multicenter, single-arm trial evaluated the safety and tolerability of tirbanibulin ointment 1% in 105 adults with 4-12 clinically typical, visible, and discrete AKs on the face or balding scalp from June to December 2022 in the United States. (In June 2024, the Food and Drug Administration approved a supplemental new drug application for tirbanibulin 1%, a microtubule inhibitor, allowing the expansion of the surface area treated for AKs of the face or scalp from 25 cm² to 100 cm².)
• Participants applied tirbanibulin ointment 1% once daily for 5 days over a treatment field of about 100 cm² on the face or balding scalp. A total of 102 patients completed the study.
• Safety and tolerability were evaluated with reports of treatment-emergent adverse events (TEAEs) and a composite score of six local tolerability signs on days 5, 8, 15, and 29, and on completion of the evaluation period on day 57.

TAKEAWAY:

• The most common local effects of treatment were erythema (96.1% of patients) and flaking or scaling (84.4%), with severe cases reported in 5.8% and 8.7% of the patients, respectively.
• The mean maximum local tolerability composite score was 4.1 out of 18, which peaked around day 8 and returned to baseline by day 29.
• TEAEs considered related to the treatment were reported in 18.1% of patients; the most frequent were application site pruritus (10.5%) and application site pain (8.6%). No adverse events led to the discontinuation of treatment.
• The mean percent reduction in the lesion count from baseline was 77.8% at day 57, with a mean lesion count of 1.8 at the end of the study.

IN PRACTICE:

In this study, “local tolerability and safety profiles were well characterized in patients with 4-12 clinically typical, visible, and discrete AK lesions in a field of 100 cm² and were consistent with those previously reported in patients with AK treated in pivotal trials with tirbanibulin over a smaller field (25 cm²),” the authors wrote.

SOURCE:

The study, led by Neal Bhatia, MD, of Therapeutics Clinical Research, San Diego, was published online in JAAD International.

LIMITATIONS:

The study was limited by the lack of a placebo group and the absence of long-term follow-up. 

DISCLOSURES:

This study was funded by Almirall. Five authors reported being employees of Almirall. Other authors declared having ties with various other sources, including Almirall.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Tirbanibulin ointment 1% shows good safety and tolerability in the treatment of actinic keratosis (AK) in fields of up to 100 cm2 on the face and scalp.

METHODOLOGY:

• This phase 3 multicenter, single-arm trial evaluated the safety and tolerability of tirbanibulin ointment 1% in 105 adults with 4-12 clinically typical, visible, and discrete AKs on the face or balding scalp from June to December 2022 in the United States. (In June 2024, the Food and Drug Administration approved a supplemental new drug application for tirbanibulin 1%, a microtubule inhibitor, allowing the expansion of the surface area treated for AKs of the face or scalp from 25 cm² to 100 cm².)
• Participants applied tirbanibulin ointment 1% once daily for 5 days over a treatment field of about 100 cm² on the face or balding scalp. A total of 102 patients completed the study.
• Safety and tolerability were evaluated with reports of treatment-emergent adverse events (TEAEs) and a composite score of six local tolerability signs on days 5, 8, 15, and 29, and on completion of the evaluation period on day 57.

TAKEAWAY:

• The most common local effects of treatment were erythema (96.1% of patients) and flaking or scaling (84.4%), with severe cases reported in 5.8% and 8.7% of the patients, respectively.
• The mean maximum local tolerability composite score was 4.1 out of 18, which peaked around day 8 and returned to baseline by day 29.
• TEAEs considered related to the treatment were reported in 18.1% of patients; the most frequent were application site pruritus (10.5%) and application site pain (8.6%). No adverse events led to the discontinuation of treatment.
• The mean percent reduction in the lesion count from baseline was 77.8% at day 57, with a mean lesion count of 1.8 at the end of the study.

IN PRACTICE:

In this study, “local tolerability and safety profiles were well characterized in patients with 4-12 clinically typical, visible, and discrete AK lesions in a field of 100 cm² and were consistent with those previously reported in patients with AK treated in pivotal trials with tirbanibulin over a smaller field (25 cm²),” the authors wrote.

SOURCE:

The study, led by Neal Bhatia, MD, of Therapeutics Clinical Research, San Diego, was published online in JAAD International.

LIMITATIONS:

The study was limited by the lack of a placebo group and the absence of long-term follow-up. 

DISCLOSURES:

This study was funded by Almirall. Five authors reported being employees of Almirall. Other authors declared having ties with various other sources, including Almirall.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

The prevalence of dermatologic conditions affecting children in refugee camps remains unclear because of the limited data on the topic, a literature review showed. However, likely culprits include infectious diseases with cutaneous manifestations, such as pediculosis, tinea capitis, and scabies.

“Current data indicates that one in two refugees are children,” one of the study investigators, Mehar Maju, MPH, a fourth-year student at of the University of Washington School of Medicine, Seattle, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the results were presented during a poster session.

Courtesy of Gary White, MD

“The number of refugees continues to rise to unprecedented levels every year,” and climate change continues to drive increases in migration, “impacting those residing in camps,” she said. “As we continue to think about what this means for best supporting those residing in camps, I think it’s also important to consider how to best support refugees, specifically children, when they arrive in the United States. Part of this is to know what conditions are most prevalent and what type of social support this vulnerable population needs.”

To identify the common dermatologic conditions among children living in refugee camps, Ms. Maju and fellow fourth-year University of Washington medical student Nadia Siddiqui searched PubMed and Google Scholar for studies that were published in English and reported on the skin disease prevalence and management for refugees who are children. Key search terms used included “refugees,” “children,” “dermatology,” and “skin disease.” Of approximately 105 potential studies identified, 19 underwent analysis. Of these, only five were included in the final review. 

One of the five studies was conducted in rural Nyala, Sudan. The study found that 88.8% of those living in orphanages and refugee camps were reported to have a skin disorder, commonly fungal or bacterial infections and dermatitis. In a separate case series, researchers found that cutaneous leishmaniasis was rising among Syrian refugee children. 

A study that looked at morbidity and disease burden in mainland Greece refugee camps found that the skin was the second-most common site of communicable diseases among children, behind those of the respiratory tract. In another study that investigated the health of children in Australian immigration detention centers, complaints related to skin conditions were significantly elevated among children who were detained offshore, compared with those who were detained onshore.

Finally, in a study of 125 children between the ages of 1 and 15 years at a Sierra Leone–based displacement camp, the prevalence of scabies was 77% among those aged < 5 years and peaked to 86% among those aged 5-9 years. 

“It was surprising to see the limited information about dermatologic diseases impacting children in refugee camps,” Ms. Maju said. “I expected that there would be more information on the specific proportion of diseases beyond those of infectious etiology. For example, I had believed that we would have more information on the prevalence of atopic dermatitis, vitiligo, and other more chronic skin diseases.” 

She acknowledged certain limitations of the analysis, mainly the lack of published information on the skin health of pediatric refugees. “A study that evaluates the health status and dermatologic prevalence of disease among children residing in camps and those newly arrived in the United States from camps would provide unprecedented insight into this topic,” Ms. Maju said. “The results could guide public health efforts in improving care delivery and preparedness in camps and clinicians serving this particular population when they arrive in the United States.”

She and Ms. Siddiqui reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

The prevalence of dermatologic conditions affecting children in refugee camps remains unclear because of the limited data on the topic, a literature review showed. However, likely culprits include infectious diseases with cutaneous manifestations, such as pediculosis, tinea capitis, and scabies.

“Current data indicates that one in two refugees are children,” one of the study investigators, Mehar Maju, MPH, a fourth-year student at of the University of Washington School of Medicine, Seattle, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the results were presented during a poster session.

Courtesy of Gary White, MD

“The number of refugees continues to rise to unprecedented levels every year,” and climate change continues to drive increases in migration, “impacting those residing in camps,” she said. “As we continue to think about what this means for best supporting those residing in camps, I think it’s also important to consider how to best support refugees, specifically children, when they arrive in the United States. Part of this is to know what conditions are most prevalent and what type of social support this vulnerable population needs.”

To identify the common dermatologic conditions among children living in refugee camps, Ms. Maju and fellow fourth-year University of Washington medical student Nadia Siddiqui searched PubMed and Google Scholar for studies that were published in English and reported on the skin disease prevalence and management for refugees who are children. Key search terms used included “refugees,” “children,” “dermatology,” and “skin disease.” Of approximately 105 potential studies identified, 19 underwent analysis. Of these, only five were included in the final review. 

One of the five studies was conducted in rural Nyala, Sudan. The study found that 88.8% of those living in orphanages and refugee camps were reported to have a skin disorder, commonly fungal or bacterial infections and dermatitis. In a separate case series, researchers found that cutaneous leishmaniasis was rising among Syrian refugee children. 

A study that looked at morbidity and disease burden in mainland Greece refugee camps found that the skin was the second-most common site of communicable diseases among children, behind those of the respiratory tract. In another study that investigated the health of children in Australian immigration detention centers, complaints related to skin conditions were significantly elevated among children who were detained offshore, compared with those who were detained onshore.

Finally, in a study of 125 children between the ages of 1 and 15 years at a Sierra Leone–based displacement camp, the prevalence of scabies was 77% among those aged < 5 years and peaked to 86% among those aged 5-9 years. 

“It was surprising to see the limited information about dermatologic diseases impacting children in refugee camps,” Ms. Maju said. “I expected that there would be more information on the specific proportion of diseases beyond those of infectious etiology. For example, I had believed that we would have more information on the prevalence of atopic dermatitis, vitiligo, and other more chronic skin diseases.” 

She acknowledged certain limitations of the analysis, mainly the lack of published information on the skin health of pediatric refugees. “A study that evaluates the health status and dermatologic prevalence of disease among children residing in camps and those newly arrived in the United States from camps would provide unprecedented insight into this topic,” Ms. Maju said. “The results could guide public health efforts in improving care delivery and preparedness in camps and clinicians serving this particular population when they arrive in the United States.”

She and Ms. Siddiqui reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

The prevalence of dermatologic conditions affecting children in refugee camps remains unclear because of the limited data on the topic, a literature review showed. However, likely culprits include infectious diseases with cutaneous manifestations, such as pediculosis, tinea capitis, and scabies.

“Current data indicates that one in two refugees are children,” one of the study investigators, Mehar Maju, MPH, a fourth-year student at of the University of Washington School of Medicine, Seattle, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the results were presented during a poster session.

Courtesy of Gary White, MD

“The number of refugees continues to rise to unprecedented levels every year,” and climate change continues to drive increases in migration, “impacting those residing in camps,” she said. “As we continue to think about what this means for best supporting those residing in camps, I think it’s also important to consider how to best support refugees, specifically children, when they arrive in the United States. Part of this is to know what conditions are most prevalent and what type of social support this vulnerable population needs.”

To identify the common dermatologic conditions among children living in refugee camps, Ms. Maju and fellow fourth-year University of Washington medical student Nadia Siddiqui searched PubMed and Google Scholar for studies that were published in English and reported on the skin disease prevalence and management for refugees who are children. Key search terms used included “refugees,” “children,” “dermatology,” and “skin disease.” Of approximately 105 potential studies identified, 19 underwent analysis. Of these, only five were included in the final review. 

One of the five studies was conducted in rural Nyala, Sudan. The study found that 88.8% of those living in orphanages and refugee camps were reported to have a skin disorder, commonly fungal or bacterial infections and dermatitis. In a separate case series, researchers found that cutaneous leishmaniasis was rising among Syrian refugee children. 

A study that looked at morbidity and disease burden in mainland Greece refugee camps found that the skin was the second-most common site of communicable diseases among children, behind those of the respiratory tract. In another study that investigated the health of children in Australian immigration detention centers, complaints related to skin conditions were significantly elevated among children who were detained offshore, compared with those who were detained onshore.

Finally, in a study of 125 children between the ages of 1 and 15 years at a Sierra Leone–based displacement camp, the prevalence of scabies was 77% among those aged < 5 years and peaked to 86% among those aged 5-9 years. 

“It was surprising to see the limited information about dermatologic diseases impacting children in refugee camps,” Ms. Maju said. “I expected that there would be more information on the specific proportion of diseases beyond those of infectious etiology. For example, I had believed that we would have more information on the prevalence of atopic dermatitis, vitiligo, and other more chronic skin diseases.” 

She acknowledged certain limitations of the analysis, mainly the lack of published information on the skin health of pediatric refugees. “A study that evaluates the health status and dermatologic prevalence of disease among children residing in camps and those newly arrived in the United States from camps would provide unprecedented insight into this topic,” Ms. Maju said. “The results could guide public health efforts in improving care delivery and preparedness in camps and clinicians serving this particular population when they arrive in the United States.”

She and Ms. Siddiqui reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

TORONTO — Lawrence A. Schachner, MD, would like pediatric dermatologists to adopt a “toxic agent of the year” to raise awareness about the potential harm related to certain topical treatments in babies and young children.

Dr. Schachner, director of the Division of Pediatric Dermatology in the Department of Dermatology & Cutaneous Surgery at the University of Miami, Coral Gables, Florida, said he got the idea from the American Contact Dermatitis Society, which annually names the “Allergen of the Year.”

In pediatric dermatology, the list of potentially toxic products includes topical analgesics such as Castellani paint used for skin infections, alcohols used for umbilical care in newborns, and henna dye used in cosmetics, said Dr. Schachner, professor of pediatrics and dermatology at the University of Miami.

“Any one of those would be excellent toxic substances of the year” that could be the focus of an educational campaign, he told this news organization following his presentation on “Toxicology of Topical Ingredients in Pediatric Dermatology” at the annual meeting of the Society for Pediatric Dermatology on July 14.

Benzene might also be a good candidate for the list, although the jury seems to be still out on its toxicity, said Dr. Schachner.

He talked about the “four Ps” of poisoning — the physician, pharmacy, parents, and pharmaceutical manufacturing — which all have some responsibility for errors that lead to adverse outcomes but can also take steps to prevent them.

During his presentation, Dr. Schachner discussed how babies are especially sensitive to topical therapies, noting that a baby’s skin is thinner and more permeable than that of an adult. And children have a greater body surface-to-weight ratio, so they absorb more substances through their skin.

He also noted that babies lack natural moisturizing factors, and their skin barrier isn’t mature until about age 3-5 years, stressing the need for extreme care when applying a topical agent to a baby’s skin.

Tragic Stories

Dr. Schachner pointed to some instances of mishaps related to toxic topical substances in children. There was the outbreak in the early 1980s of accidental hexachlorophene poisoning among children in France exposed to talc “baby powder.” Of the 204 affected children, 36 died.

The cause was a manufacturing error; the product contained 6.3% hexachlorophene, as opposed to the 0.1% limit recommended by the US Food and Drug Administration (FDA).

Local anesthetics, including lidocaine, dibucaine, and prilocaine, can cause local anesthetic systemic toxicity, a syndrome with symptoms that include central nervous system depression, seizures, and cardiotoxicity. Dr. Schachner described the case of a 3-year-old who developed methemoglobinemia, with seizures, after treatment with an excessive amount of eutectic mixture of local anesthetics (EMLA) cream, which contains both lidocaine and prilocaine.

EMLA shouldn’t be used with methemoglobinemia-inducing agents, such as some antimalarials, analgesics, anesthetics, and antineoplastic agents. It’s not recommended in neonates or for those under 12 months if receiving methemoglobinemia-inducing agents, “and I would keep an eye on it after 12 months of age,” said Dr. Schachner.

He cited a retrospective review of topical lidocaine toxicity in pediatric patients reported to the National Poison Data System from 2000 to 2020. It found 37 cases of toxicity, the most common from application prior to dermatologic procedures (37.5%), which led to two deaths.
 

Not Benign Agents

“These are not benign agents; we have to use them correctly,” Dr. Schachner stressed. When discussing alcohols and antiseptics, he noted that phenol is found in a variety of household disinfectants, gargling products, ointments, and lip balms. Phenol can be used as a chemical peel and is the antiseptic component of Castellani paint. He also referred to cases of alcohol intoxication linked to umbilical care in newborns.

Benzene at elevated levels has been found in some topical benzoyl peroxide acne products and in some sunscreens. There have been suggestions, not strongly substantiated, that benzene may increase the risk for cancer, especially leukemias.

But there is sparse data on the absorption and toxicity of benzene exposure with sunscreen use. The data, he said, include an analysis of National Health and Nutrition Examination Survey data, which found that people who regularly used sunscreens were less likely to have elevated benzene levels compared with those who didn’t use sunscreens.

Turning to insecticides, Dr. Schachner discussed N,N-diethyl-m-toluamide (DEET), the active ingredient in many insect repellents. It helps avoid “some terrible diseases,” including mosquito-borne illnesses such as malaria and tick-borne conditions such as Lyme disease, and is available in several convenient formulations, he said.

When used on children, the American Academy of Pediatrics (AAP) recommends products with no more than 30% DEET. And insect repellents are not recommended for children younger than 2 months, or under clothing or damaged skin, he said.

Dr. Schachner referred to a case series of 18 children who developed DEET-induced encephalopathy; 13 (72%) involved dermal exposure. Three of those with cutaneous exposure died, mostly from neurologic, respiratory, and cardiac issues. “What’s very striking is that 55% of the kids were exposed to DEET of 20% or less, even though the AAP approves DEET at 30%, so maybe that’s something we have to look at,” he said.
 

Medication Patches

With medication patches, especially fentanyl transdermal patches, much can go wrong when it comes to children. This was highlighted by the cases Schachner cited, including an infant who developed acute cytotoxic cerebellar edema from fentanyl patch intoxication.

In another case, emergency room staff found a fentanyl patch stuck to the back of a 3-year-old girl. A CT scan showed global cerebral edema, and the patient progressed to brain death. “This is not a unique case; there have been over 10 such cases in the United States,” said Dr. Schachner. “We should be doing better with fentanyl.”

Nicotine patches can also be dangerous to children, he added. As for other topical agents, there have been reports of toxicity and deaths linked to salicylic acid, commonly used by dermatologists because of its bacteriostatic, fungicidal, keratolytic, and photoprotective properties.

Dr. Schachner cited the case of a 2-month-old where the pediatrician prescribed 50% salicylic acid for seborrheic dermatitis of the scalp, under occlusion. “It’s amazing this child survived; that’s clearly a physician error,” he said.

Henna, a reddish-brown dye derived from the crushed leaves of Lawsonia alba, is used cosmetically for the hair, skin, and nails. Many henna products are mixed with additives, including para-phenylenediamine, which has been associated with dermatitis, asthma, renal failure, and permanent vision loss.

Asked to comment on the presentation, Sheilagh Maguiness, MD, professor of dermatology and pediatrics and chair of pediatric dermatology at the University of Minnesota, Minneapolis, recalled a particularly concerning story in 2008, when the FDA issued a warning about Mommy’s Bliss, a cream containing chlorphenesin and phenoxyethanol as preservatives, promoted to nursing mothers for soothing cracked nipples. There were reports of the cream causing respiratory distress, vomiting, and diarrhea in nursing infants.

Dr. Schachner is chair of Stiefel Laboratories and is an investigator with: Astellas, Berg Pharma, Celgene, Ferndale Labs, Lilly, Medimetriks Pharmaceuticals, Novartis, Organogenesis, Pfizer, Sciton; is a consultant for: Alphyn, Amryt Pharma, Beiersdorf, Brickell, Cutanea, Hoth, Lexington, Mustela, TopMD, Noble Pharma; a speaker for: Novartis, Sanofi-Regeneron, CeraVe; is on the advisory boards of: Almirall, Alphyn, Apogee, Aslan, Biofrontera, CeraVe, Krystal Biotech, Mustela, Noble Pharma, Pfizer, Pierre Fabre, Sanofi-Regeneron; and owns stocks in: TopMD and Alphyn. Dr. Maguiness had no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TORONTO — Lawrence A. Schachner, MD, would like pediatric dermatologists to adopt a “toxic agent of the year” to raise awareness about the potential harm related to certain topical treatments in babies and young children.

Dr. Schachner, director of the Division of Pediatric Dermatology in the Department of Dermatology & Cutaneous Surgery at the University of Miami, Coral Gables, Florida, said he got the idea from the American Contact Dermatitis Society, which annually names the “Allergen of the Year.”

In pediatric dermatology, the list of potentially toxic products includes topical analgesics such as Castellani paint used for skin infections, alcohols used for umbilical care in newborns, and henna dye used in cosmetics, said Dr. Schachner, professor of pediatrics and dermatology at the University of Miami.

“Any one of those would be excellent toxic substances of the year” that could be the focus of an educational campaign, he told this news organization following his presentation on “Toxicology of Topical Ingredients in Pediatric Dermatology” at the annual meeting of the Society for Pediatric Dermatology on July 14.

Benzene might also be a good candidate for the list, although the jury seems to be still out on its toxicity, said Dr. Schachner.

He talked about the “four Ps” of poisoning — the physician, pharmacy, parents, and pharmaceutical manufacturing — which all have some responsibility for errors that lead to adverse outcomes but can also take steps to prevent them.

During his presentation, Dr. Schachner discussed how babies are especially sensitive to topical therapies, noting that a baby’s skin is thinner and more permeable than that of an adult. And children have a greater body surface-to-weight ratio, so they absorb more substances through their skin.

He also noted that babies lack natural moisturizing factors, and their skin barrier isn’t mature until about age 3-5 years, stressing the need for extreme care when applying a topical agent to a baby’s skin.

Tragic Stories

Dr. Schachner pointed to some instances of mishaps related to toxic topical substances in children. There was the outbreak in the early 1980s of accidental hexachlorophene poisoning among children in France exposed to talc “baby powder.” Of the 204 affected children, 36 died.

The cause was a manufacturing error; the product contained 6.3% hexachlorophene, as opposed to the 0.1% limit recommended by the US Food and Drug Administration (FDA).

Local anesthetics, including lidocaine, dibucaine, and prilocaine, can cause local anesthetic systemic toxicity, a syndrome with symptoms that include central nervous system depression, seizures, and cardiotoxicity. Dr. Schachner described the case of a 3-year-old who developed methemoglobinemia, with seizures, after treatment with an excessive amount of eutectic mixture of local anesthetics (EMLA) cream, which contains both lidocaine and prilocaine.

EMLA shouldn’t be used with methemoglobinemia-inducing agents, such as some antimalarials, analgesics, anesthetics, and antineoplastic agents. It’s not recommended in neonates or for those under 12 months if receiving methemoglobinemia-inducing agents, “and I would keep an eye on it after 12 months of age,” said Dr. Schachner.

He cited a retrospective review of topical lidocaine toxicity in pediatric patients reported to the National Poison Data System from 2000 to 2020. It found 37 cases of toxicity, the most common from application prior to dermatologic procedures (37.5%), which led to two deaths.
 

Not Benign Agents

“These are not benign agents; we have to use them correctly,” Dr. Schachner stressed. When discussing alcohols and antiseptics, he noted that phenol is found in a variety of household disinfectants, gargling products, ointments, and lip balms. Phenol can be used as a chemical peel and is the antiseptic component of Castellani paint. He also referred to cases of alcohol intoxication linked to umbilical care in newborns.

Benzene at elevated levels has been found in some topical benzoyl peroxide acne products and in some sunscreens. There have been suggestions, not strongly substantiated, that benzene may increase the risk for cancer, especially leukemias.

But there is sparse data on the absorption and toxicity of benzene exposure with sunscreen use. The data, he said, include an analysis of National Health and Nutrition Examination Survey data, which found that people who regularly used sunscreens were less likely to have elevated benzene levels compared with those who didn’t use sunscreens.

Turning to insecticides, Dr. Schachner discussed N,N-diethyl-m-toluamide (DEET), the active ingredient in many insect repellents. It helps avoid “some terrible diseases,” including mosquito-borne illnesses such as malaria and tick-borne conditions such as Lyme disease, and is available in several convenient formulations, he said.

When used on children, the American Academy of Pediatrics (AAP) recommends products with no more than 30% DEET. And insect repellents are not recommended for children younger than 2 months, or under clothing or damaged skin, he said.

Dr. Schachner referred to a case series of 18 children who developed DEET-induced encephalopathy; 13 (72%) involved dermal exposure. Three of those with cutaneous exposure died, mostly from neurologic, respiratory, and cardiac issues. “What’s very striking is that 55% of the kids were exposed to DEET of 20% or less, even though the AAP approves DEET at 30%, so maybe that’s something we have to look at,” he said.
 

Medication Patches

With medication patches, especially fentanyl transdermal patches, much can go wrong when it comes to children. This was highlighted by the cases Schachner cited, including an infant who developed acute cytotoxic cerebellar edema from fentanyl patch intoxication.

In another case, emergency room staff found a fentanyl patch stuck to the back of a 3-year-old girl. A CT scan showed global cerebral edema, and the patient progressed to brain death. “This is not a unique case; there have been over 10 such cases in the United States,” said Dr. Schachner. “We should be doing better with fentanyl.”

Nicotine patches can also be dangerous to children, he added. As for other topical agents, there have been reports of toxicity and deaths linked to salicylic acid, commonly used by dermatologists because of its bacteriostatic, fungicidal, keratolytic, and photoprotective properties.

Dr. Schachner cited the case of a 2-month-old where the pediatrician prescribed 50% salicylic acid for seborrheic dermatitis of the scalp, under occlusion. “It’s amazing this child survived; that’s clearly a physician error,” he said.

Henna, a reddish-brown dye derived from the crushed leaves of Lawsonia alba, is used cosmetically for the hair, skin, and nails. Many henna products are mixed with additives, including para-phenylenediamine, which has been associated with dermatitis, asthma, renal failure, and permanent vision loss.

Asked to comment on the presentation, Sheilagh Maguiness, MD, professor of dermatology and pediatrics and chair of pediatric dermatology at the University of Minnesota, Minneapolis, recalled a particularly concerning story in 2008, when the FDA issued a warning about Mommy’s Bliss, a cream containing chlorphenesin and phenoxyethanol as preservatives, promoted to nursing mothers for soothing cracked nipples. There were reports of the cream causing respiratory distress, vomiting, and diarrhea in nursing infants.

Dr. Schachner is chair of Stiefel Laboratories and is an investigator with: Astellas, Berg Pharma, Celgene, Ferndale Labs, Lilly, Medimetriks Pharmaceuticals, Novartis, Organogenesis, Pfizer, Sciton; is a consultant for: Alphyn, Amryt Pharma, Beiersdorf, Brickell, Cutanea, Hoth, Lexington, Mustela, TopMD, Noble Pharma; a speaker for: Novartis, Sanofi-Regeneron, CeraVe; is on the advisory boards of: Almirall, Alphyn, Apogee, Aslan, Biofrontera, CeraVe, Krystal Biotech, Mustela, Noble Pharma, Pfizer, Pierre Fabre, Sanofi-Regeneron; and owns stocks in: TopMD and Alphyn. Dr. Maguiness had no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TORONTO — Lawrence A. Schachner, MD, would like pediatric dermatologists to adopt a “toxic agent of the year” to raise awareness about the potential harm related to certain topical treatments in babies and young children.

Dr. Schachner, director of the Division of Pediatric Dermatology in the Department of Dermatology & Cutaneous Surgery at the University of Miami, Coral Gables, Florida, said he got the idea from the American Contact Dermatitis Society, which annually names the “Allergen of the Year.”

In pediatric dermatology, the list of potentially toxic products includes topical analgesics such as Castellani paint used for skin infections, alcohols used for umbilical care in newborns, and henna dye used in cosmetics, said Dr. Schachner, professor of pediatrics and dermatology at the University of Miami.

“Any one of those would be excellent toxic substances of the year” that could be the focus of an educational campaign, he told this news organization following his presentation on “Toxicology of Topical Ingredients in Pediatric Dermatology” at the annual meeting of the Society for Pediatric Dermatology on July 14.

Benzene might also be a good candidate for the list, although the jury seems to be still out on its toxicity, said Dr. Schachner.

He talked about the “four Ps” of poisoning — the physician, pharmacy, parents, and pharmaceutical manufacturing — which all have some responsibility for errors that lead to adverse outcomes but can also take steps to prevent them.

During his presentation, Dr. Schachner discussed how babies are especially sensitive to topical therapies, noting that a baby’s skin is thinner and more permeable than that of an adult. And children have a greater body surface-to-weight ratio, so they absorb more substances through their skin.

He also noted that babies lack natural moisturizing factors, and their skin barrier isn’t mature until about age 3-5 years, stressing the need for extreme care when applying a topical agent to a baby’s skin.

Tragic Stories

Dr. Schachner pointed to some instances of mishaps related to toxic topical substances in children. There was the outbreak in the early 1980s of accidental hexachlorophene poisoning among children in France exposed to talc “baby powder.” Of the 204 affected children, 36 died.

The cause was a manufacturing error; the product contained 6.3% hexachlorophene, as opposed to the 0.1% limit recommended by the US Food and Drug Administration (FDA).

Local anesthetics, including lidocaine, dibucaine, and prilocaine, can cause local anesthetic systemic toxicity, a syndrome with symptoms that include central nervous system depression, seizures, and cardiotoxicity. Dr. Schachner described the case of a 3-year-old who developed methemoglobinemia, with seizures, after treatment with an excessive amount of eutectic mixture of local anesthetics (EMLA) cream, which contains both lidocaine and prilocaine.

EMLA shouldn’t be used with methemoglobinemia-inducing agents, such as some antimalarials, analgesics, anesthetics, and antineoplastic agents. It’s not recommended in neonates or for those under 12 months if receiving methemoglobinemia-inducing agents, “and I would keep an eye on it after 12 months of age,” said Dr. Schachner.

He cited a retrospective review of topical lidocaine toxicity in pediatric patients reported to the National Poison Data System from 2000 to 2020. It found 37 cases of toxicity, the most common from application prior to dermatologic procedures (37.5%), which led to two deaths.
 

Not Benign Agents

“These are not benign agents; we have to use them correctly,” Dr. Schachner stressed. When discussing alcohols and antiseptics, he noted that phenol is found in a variety of household disinfectants, gargling products, ointments, and lip balms. Phenol can be used as a chemical peel and is the antiseptic component of Castellani paint. He also referred to cases of alcohol intoxication linked to umbilical care in newborns.

Benzene at elevated levels has been found in some topical benzoyl peroxide acne products and in some sunscreens. There have been suggestions, not strongly substantiated, that benzene may increase the risk for cancer, especially leukemias.

But there is sparse data on the absorption and toxicity of benzene exposure with sunscreen use. The data, he said, include an analysis of National Health and Nutrition Examination Survey data, which found that people who regularly used sunscreens were less likely to have elevated benzene levels compared with those who didn’t use sunscreens.

Turning to insecticides, Dr. Schachner discussed N,N-diethyl-m-toluamide (DEET), the active ingredient in many insect repellents. It helps avoid “some terrible diseases,” including mosquito-borne illnesses such as malaria and tick-borne conditions such as Lyme disease, and is available in several convenient formulations, he said.

When used on children, the American Academy of Pediatrics (AAP) recommends products with no more than 30% DEET. And insect repellents are not recommended for children younger than 2 months, or under clothing or damaged skin, he said.

Dr. Schachner referred to a case series of 18 children who developed DEET-induced encephalopathy; 13 (72%) involved dermal exposure. Three of those with cutaneous exposure died, mostly from neurologic, respiratory, and cardiac issues. “What’s very striking is that 55% of the kids were exposed to DEET of 20% or less, even though the AAP approves DEET at 30%, so maybe that’s something we have to look at,” he said.
 

Medication Patches

With medication patches, especially fentanyl transdermal patches, much can go wrong when it comes to children. This was highlighted by the cases Schachner cited, including an infant who developed acute cytotoxic cerebellar edema from fentanyl patch intoxication.

In another case, emergency room staff found a fentanyl patch stuck to the back of a 3-year-old girl. A CT scan showed global cerebral edema, and the patient progressed to brain death. “This is not a unique case; there have been over 10 such cases in the United States,” said Dr. Schachner. “We should be doing better with fentanyl.”

Nicotine patches can also be dangerous to children, he added. As for other topical agents, there have been reports of toxicity and deaths linked to salicylic acid, commonly used by dermatologists because of its bacteriostatic, fungicidal, keratolytic, and photoprotective properties.

Dr. Schachner cited the case of a 2-month-old where the pediatrician prescribed 50% salicylic acid for seborrheic dermatitis of the scalp, under occlusion. “It’s amazing this child survived; that’s clearly a physician error,” he said.

Henna, a reddish-brown dye derived from the crushed leaves of Lawsonia alba, is used cosmetically for the hair, skin, and nails. Many henna products are mixed with additives, including para-phenylenediamine, which has been associated with dermatitis, asthma, renal failure, and permanent vision loss.

Asked to comment on the presentation, Sheilagh Maguiness, MD, professor of dermatology and pediatrics and chair of pediatric dermatology at the University of Minnesota, Minneapolis, recalled a particularly concerning story in 2008, when the FDA issued a warning about Mommy’s Bliss, a cream containing chlorphenesin and phenoxyethanol as preservatives, promoted to nursing mothers for soothing cracked nipples. There were reports of the cream causing respiratory distress, vomiting, and diarrhea in nursing infants.

Dr. Schachner is chair of Stiefel Laboratories and is an investigator with: Astellas, Berg Pharma, Celgene, Ferndale Labs, Lilly, Medimetriks Pharmaceuticals, Novartis, Organogenesis, Pfizer, Sciton; is a consultant for: Alphyn, Amryt Pharma, Beiersdorf, Brickell, Cutanea, Hoth, Lexington, Mustela, TopMD, Noble Pharma; a speaker for: Novartis, Sanofi-Regeneron, CeraVe; is on the advisory boards of: Almirall, Alphyn, Apogee, Aslan, Biofrontera, CeraVe, Krystal Biotech, Mustela, Noble Pharma, Pfizer, Pierre Fabre, Sanofi-Regeneron; and owns stocks in: TopMD and Alphyn. Dr. Maguiness had no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).

Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).

Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).

Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

When Black, Hispanic, and American Indian/Alaska Native parents or guardians were asked about barriers and facilitators to accessing pediatric dermatology care for their children, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.

“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”

Dr. Kohn

As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.

The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.

“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”

One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).

Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”

The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.

A version of this article appeared on Medscape.com.

When Black, Hispanic, and American Indian/Alaska Native parents or guardians were asked about barriers and facilitators to accessing pediatric dermatology care for their children, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.

“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”

Dr. Kohn

As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.

The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.

“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”

One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).

Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”

The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.

A version of this article appeared on Medscape.com.

When Black, Hispanic, and American Indian/Alaska Native parents or guardians were asked about barriers and facilitators to accessing pediatric dermatology care for their children, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.

“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”

Dr. Kohn

As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.

The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.

“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”

One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).

Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”

The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.

A version of this article appeared on Medscape.com.

Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”

The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”

The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”

The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib for the treatment of adults with severe alopecia areata.

The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).

In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.

Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older. 

In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib for the treatment of adults with severe alopecia areata.

The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).

In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.

Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older. 

In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib for the treatment of adults with severe alopecia areata.

The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).

In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.

Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older. 

In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”

A version of this article first appeared on Medscape.com.

Application of an investigative topical cannabidiol (CBD) cream to buttock skin demonstrated protective properties against ultraviolet A (UVA) radiation-induced DNA and mitochondrial DNA damage, results from a small prospective pilot study showed.

“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.

George Washington University

For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.

At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.

In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.

The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.

“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.

In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.

Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.

A version of this article first appeared on Medscape.com.

Application of an investigative topical cannabidiol (CBD) cream to buttock skin demonstrated protective properties against ultraviolet A (UVA) radiation-induced DNA and mitochondrial DNA damage, results from a small prospective pilot study showed.

“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.

George Washington University

For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.

At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.

In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.

The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.

“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.

In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.

Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.

A version of this article first appeared on Medscape.com.

Application of an investigative topical cannabidiol (CBD) cream to buttock skin demonstrated protective properties against ultraviolet A (UVA) radiation-induced DNA and mitochondrial DNA damage, results from a small prospective pilot study showed.

“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.

George Washington University

For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.

At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.

In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.

The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.

“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.

In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.

Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.

A version of this article first appeared on Medscape.com.

TOPLINE:

More gastrointestinal and nervous symptom adverse events (AEs) are linked to apremilast than deucravacitinib, which is associated with more cutaneous AEs, according to a retrospective comparison using US Food and Drug Administration (FDA) data.

METHODOLOGY:

• To evaluate the adverse events associated with apremilast, an oral phosphodiesterase-4 (PDE4) inhibitor, and deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, data were drawn from the FDA’s Adverse Event Reporting System database.
• The Medex_UIMA_1.8.3 system was used to standardize drug names, and MedDRA terminology was used to encode, categorize, and localize signals.
• AE event signals were grouped by skin and subcutaneous tissue disorders, gastrointestinal disorders, infections and infestations, and nervous system disorders.

TAKEAWAY:

• There were 95,734 AE reports for apremilast and 760 AE reports for deucravacitinib, and AEs were found to be significant over time.
• The more common cutaneous AEs were psoriasis recurrence and acne (associated with apremilast) and skin burning and erythema (associated with deucravacitinib).
• The more common gastrointestinal AEs were diarrhea and nausea (apremilast) and mouth ulceration (deucravacitinib).
• Deucravacitinib-related pruritus and rash, as well as apremilast-related tension headache, were more common in women than men; deucravacitinib-related skin burning was more common in men.

IN PRACTICE:

The results “can help the doctors to choose the right treatment options based on the baseline characteristics of different patients,” said Yuanyuan Xu, a graduate student in the Department of Dermatology, Sichuan University, Chengdu, China.

SOURCE:

Mr. Xu presented the study as a poster at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2024 annual meeting.

LIMITATIONS:

The study was retrospective and cannot prove causality, and there were far fewer AE reports related to deucravacitinib, likely because the drug was introduced more recently.

DISCLOSURES:

The study received no funding, and the authors had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

More gastrointestinal and nervous symptom adverse events (AEs) are linked to apremilast than deucravacitinib, which is associated with more cutaneous AEs, according to a retrospective comparison using US Food and Drug Administration (FDA) data.

METHODOLOGY:

• To evaluate the adverse events associated with apremilast, an oral phosphodiesterase-4 (PDE4) inhibitor, and deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, data were drawn from the FDA’s Adverse Event Reporting System database.
• The Medex_UIMA_1.8.3 system was used to standardize drug names, and MedDRA terminology was used to encode, categorize, and localize signals.
• AE event signals were grouped by skin and subcutaneous tissue disorders, gastrointestinal disorders, infections and infestations, and nervous system disorders.

TAKEAWAY:

• There were 95,734 AE reports for apremilast and 760 AE reports for deucravacitinib, and AEs were found to be significant over time.
• The more common cutaneous AEs were psoriasis recurrence and acne (associated with apremilast) and skin burning and erythema (associated with deucravacitinib).
• The more common gastrointestinal AEs were diarrhea and nausea (apremilast) and mouth ulceration (deucravacitinib).
• Deucravacitinib-related pruritus and rash, as well as apremilast-related tension headache, were more common in women than men; deucravacitinib-related skin burning was more common in men.

IN PRACTICE:

The results “can help the doctors to choose the right treatment options based on the baseline characteristics of different patients,” said Yuanyuan Xu, a graduate student in the Department of Dermatology, Sichuan University, Chengdu, China.

SOURCE:

Mr. Xu presented the study as a poster at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2024 annual meeting.

LIMITATIONS:

The study was retrospective and cannot prove causality, and there were far fewer AE reports related to deucravacitinib, likely because the drug was introduced more recently.

DISCLOSURES:

The study received no funding, and the authors had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

More gastrointestinal and nervous symptom adverse events (AEs) are linked to apremilast than deucravacitinib, which is associated with more cutaneous AEs, according to a retrospective comparison using US Food and Drug Administration (FDA) data.

METHODOLOGY:

• To evaluate the adverse events associated with apremilast, an oral phosphodiesterase-4 (PDE4) inhibitor, and deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, data were drawn from the FDA’s Adverse Event Reporting System database.
• The Medex_UIMA_1.8.3 system was used to standardize drug names, and MedDRA terminology was used to encode, categorize, and localize signals.
• AE event signals were grouped by skin and subcutaneous tissue disorders, gastrointestinal disorders, infections and infestations, and nervous system disorders.

TAKEAWAY:

• There were 95,734 AE reports for apremilast and 760 AE reports for deucravacitinib, and AEs were found to be significant over time.
• The more common cutaneous AEs were psoriasis recurrence and acne (associated with apremilast) and skin burning and erythema (associated with deucravacitinib).
• The more common gastrointestinal AEs were diarrhea and nausea (apremilast) and mouth ulceration (deucravacitinib).
• Deucravacitinib-related pruritus and rash, as well as apremilast-related tension headache, were more common in women than men; deucravacitinib-related skin burning was more common in men.

IN PRACTICE:

The results “can help the doctors to choose the right treatment options based on the baseline characteristics of different patients,” said Yuanyuan Xu, a graduate student in the Department of Dermatology, Sichuan University, Chengdu, China.

SOURCE:

Mr. Xu presented the study as a poster at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2024 annual meeting.

LIMITATIONS:

The study was retrospective and cannot prove causality, and there were far fewer AE reports related to deucravacitinib, likely because the drug was introduced more recently.

DISCLOSURES:

The study received no funding, and the authors had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.