Aesthetic Dermatology

Cimzia

UCB, Inc, obtains US Food and Drug Administration approval of Cimzia (certolizumab pegol), a tumor necrosis factor blocker for the treatment of active psoriatic arthritis in adults. Cimzia also is indicated in adults for the treatment of moderate to severe rheumatoid arthritis and to reduce signs and symptoms of moderately to severely active Crohn disease. For more information, visit www.cimzia.com.

La Roche-Posay Antiaging Products

La Roche-Posay Laboratoire Dermatologique releases 3 antiaging products: Mela-D Deep Cleansing Brightening Foaming Cream, Redermic [R] Eyes, and Substiane [+] Serum. The Mela-D product is a deep-cleansing and brightening formula with lipohy-droxy acid that combats dark spots and gives the skin a clean and smooth appearance. Redermic [R] Eyes combines 0.01% pure retinol with a retinol booster complex and caffeine to reduce crow’s-feet and dark circles to rejuvenate the eye area. Substiane [+] Serum increases the volume and elasticity of the skin. All products are physician dispensed or available in select drugstores and online. For more information, visit www.laroche-posay.us.

Otrexup

Antares Pharma Inc obtains US Food and Drug Administration approval of Otrexup (methotrexate), a folate analog metabolic inhibitor for the treatment of severe, recalcitrant, disabling psoriasis in adults who have not responded to other therapies. Otrexup is self-administered subcutaneously once weekly via an easy-to-use, single-dose, disposable autoinjector, which utilizes Vibex Medi-Jet technology. Otrexup also is indicated for adults with severe active rheumatoid arthritis and for children with active polyarticular juvenile idiopathic arthritis. For more information, visit www.otrexup.com.

Valeant Partners With National Coalition Against Domestic

Violence Valeant Pharmaceuticals International, Inc, announces a partnership with the National Coalition Against Domestic Violence (NCADV) to help improve the lives of women. Valeant pledges to donate a portion of sales from Medicis and Obagi products to support the initiatives of the NCADV. For more information, visit enddomesticviolence.valeant.com.

If you would like your product included in Product News, please e-mail a press release to Melissa Steiger at msteiger@frontlinemedcom.com.

Cimzia

UCB, Inc, obtains US Food and Drug Administration approval of Cimzia (certolizumab pegol), a tumor necrosis factor blocker for the treatment of active psoriatic arthritis in adults. Cimzia also is indicated in adults for the treatment of moderate to severe rheumatoid arthritis and to reduce signs and symptoms of moderately to severely active Crohn disease. For more information, visit www.cimzia.com.

La Roche-Posay Antiaging Products

La Roche-Posay Laboratoire Dermatologique releases 3 antiaging products: Mela-D Deep Cleansing Brightening Foaming Cream, Redermic [R] Eyes, and Substiane [+] Serum. The Mela-D product is a deep-cleansing and brightening formula with lipohy-droxy acid that combats dark spots and gives the skin a clean and smooth appearance. Redermic [R] Eyes combines 0.01% pure retinol with a retinol booster complex and caffeine to reduce crow’s-feet and dark circles to rejuvenate the eye area. Substiane [+] Serum increases the volume and elasticity of the skin. All products are physician dispensed or available in select drugstores and online. For more information, visit www.laroche-posay.us.

Otrexup

Antares Pharma Inc obtains US Food and Drug Administration approval of Otrexup (methotrexate), a folate analog metabolic inhibitor for the treatment of severe, recalcitrant, disabling psoriasis in adults who have not responded to other therapies. Otrexup is self-administered subcutaneously once weekly via an easy-to-use, single-dose, disposable autoinjector, which utilizes Vibex Medi-Jet technology. Otrexup also is indicated for adults with severe active rheumatoid arthritis and for children with active polyarticular juvenile idiopathic arthritis. For more information, visit www.otrexup.com.

Valeant Partners With National Coalition Against Domestic

Violence Valeant Pharmaceuticals International, Inc, announces a partnership with the National Coalition Against Domestic Violence (NCADV) to help improve the lives of women. Valeant pledges to donate a portion of sales from Medicis and Obagi products to support the initiatives of the NCADV. For more information, visit enddomesticviolence.valeant.com.

If you would like your product included in Product News, please e-mail a press release to Melissa Steiger at msteiger@frontlinemedcom.com.

Cimzia

UCB, Inc, obtains US Food and Drug Administration approval of Cimzia (certolizumab pegol), a tumor necrosis factor blocker for the treatment of active psoriatic arthritis in adults. Cimzia also is indicated in adults for the treatment of moderate to severe rheumatoid arthritis and to reduce signs and symptoms of moderately to severely active Crohn disease. For more information, visit www.cimzia.com.

La Roche-Posay Antiaging Products

La Roche-Posay Laboratoire Dermatologique releases 3 antiaging products: Mela-D Deep Cleansing Brightening Foaming Cream, Redermic [R] Eyes, and Substiane [+] Serum. The Mela-D product is a deep-cleansing and brightening formula with lipohy-droxy acid that combats dark spots and gives the skin a clean and smooth appearance. Redermic [R] Eyes combines 0.01% pure retinol with a retinol booster complex and caffeine to reduce crow’s-feet and dark circles to rejuvenate the eye area. Substiane [+] Serum increases the volume and elasticity of the skin. All products are physician dispensed or available in select drugstores and online. For more information, visit www.laroche-posay.us.

Otrexup

Antares Pharma Inc obtains US Food and Drug Administration approval of Otrexup (methotrexate), a folate analog metabolic inhibitor for the treatment of severe, recalcitrant, disabling psoriasis in adults who have not responded to other therapies. Otrexup is self-administered subcutaneously once weekly via an easy-to-use, single-dose, disposable autoinjector, which utilizes Vibex Medi-Jet technology. Otrexup also is indicated for adults with severe active rheumatoid arthritis and for children with active polyarticular juvenile idiopathic arthritis. For more information, visit www.otrexup.com.

Valeant Partners With National Coalition Against Domestic

Violence Valeant Pharmaceuticals International, Inc, announces a partnership with the National Coalition Against Domestic Violence (NCADV) to help improve the lives of women. Valeant pledges to donate a portion of sales from Medicis and Obagi products to support the initiatives of the NCADV. For more information, visit enddomesticviolence.valeant.com.

If you would like your product included in Product News, please e-mail a press release to Melissa Steiger at msteiger@frontlinemedcom.com.

WOODINVILLE, WASH. – Make decisions about whether to surgically or medically manage keloids according to features of the lesion and patient-related factors, especially likely treatment compliance, Dr. Hilary E. Baldwin advised.

"Step one when we are dealing with our patients with keloids is trying to decide what the patients actually hope for," Dr. Baldwin said at the annual Coastal Dermatology Symposium. That might be eradication of the keloid; palliation of symptoms such as itching or pain; flattening, lightening, or softening of the keloid; ability to wear clip-on earrings; or restoration of mobility.

"Most patients, in my opinion, are actually not surgical candidates, and most need to be convinced to pursue other options," said Dr. Baldwin of the dermatology department at the State University of New York, Brooklyn.

Surgical management

Size and shape should factor into decisions about surgical removal of keloids, said Dr. Baldwin. Larger keloids are not much more difficult to remove than smaller ones, and pedunculated keloids are generally the most amenable to surgery, she noted.

Keloid age also comes into play, as the older, mature, brown lesions are less likely to recur after surgery than the younger, pink, symptomatic ones. Location affects outcome as well, Dr. Baldwin said. Keloids on the jaw, the deltoid, mid-back, mid-chest, and upper back are most likely to recur if treated surgically, and those in low-tension areas are less likely to do so.

Surgery also may be considered for keloids that are truly unresponsive to intralesional corticosteroids, but those are uncommon as previous lack of response is usually because of an inadequate dose, Dr. Baldwin explained.

"Most important is patient commitment. They often believe that cutting is a quick fix and they are not going to have to do anything afterward, and they are poor flight risks because of that," she said. Statistics suggest that the nearly 100% of keloids recur with surgery alone, but the value falls to 50% with adjunctive corticosteroids, and 20% with adjunctive radiation therapy, she added.

Adjunctive therapies

When adjunctive corticosteroids are used after surgery, the steroid is injected into the base and walls of the excision site, according to Dr. Baldwin; her preference is to use 40 mg/cc triamcinolone, with injections given for at least 6 months.

"Radiation therapy ... works really well postop; in fact, it’s our best adjunctive therapy, if you’re not afraid of it and the patient’s not afraid of it," she said. At her institution, this therapy is completed within a week after surgery, "so even if patients are a flight risk, they always return for that first visit, and then they are done with at least one adjunctive therapy."

The main barrier to use has been a fear of secondary malignancy. But reports of cancer after radiation therapy are rare and questionably associated with the treatment, Dr. Baldwin said.

Pressure dressings also are effective, and these are most practical in the form of compression earrings worn after excision of earlobe keloids, usually for at least 6 months. The earrings also come in a form called "sleepers" that may be more acceptable to patients.

Interferon injections also can help prevent recurrence. "I treat the very first day ... into the wall and into the base, just as I would with steroids, and then repeat 1 week later," Dr. Baldwin explained. "So if you use this and radiation therapy, 1 week later, you have finished two adjunctive therapies."

Especially challenging are keloids nearly obliterating normal tissue, such as extensive earlobe keloids. "I call them last-chance keloids," Dr. Baldwin commented. "If I don’t do a good job and don’t have good adjunctive therapy, it’s going to regrow and that’s the last time I am going to be able to cut. The earlobe will be eaten away with keloid, and we are never going to be able to give [the patient] an earlobe on which to hang an earring."

After excision of last-chance keloids, "I recommend that you do everything ... Use everything that is available to you," Dr. Baldwin advised. In addition to excision, that includes "intralesional steroids, intralesional interferon, radiation therapy, and earrings. Why pick one? Use them all if appropriate, and you are much less likely to have a recurrence," she said.

Medical management

Medical therapy is indicated for large, sessile keloids and for those located in areas where surgery could lead to complications, according to Dr. Baldwin.

In these cases, intralesional corticosteroids are the mainstay, and her preference is to use a high dose of triamcinolone. "I only use 40 [mg/cc]—that’s it. I never use anything less," she said. "I don’t care where the keloid is: A keloid on the face is the same as a keloid on the back. Most of the failures that I see are due to inadequate concentration. It’s almost always on the face where people are a little bit shy about using the extraordinarily high doses," she added.

Dr. Baldwin dismissed the dogma of not exceeding 40 mg per month, given that this translates to a dose of just 50 mg of prednisone. "I will sometimes use 80 [mg] in one sitting. I don’t really have that kind of a restriction because it doesn’t make a ton of sense," she said.

For pre-injection anesthesia, Dr. Baldwin recommended applying topical anesthetic followed by a lidocaine ring block. When treating hard keloids, to prevent backwash of the corticosteroid along the needle track, she said she preapplies Krazy Glue and, immediately after removing the needle, applies a strip of precut tape.

Patients should be advised of the possible complications of hypopigmentation, telangiectasia, and atrophy. "You also have to warn your patients about what I call the Play-Doh effect," whereby the keloid spreads as it softens, Dr. Baldwin said. "So the footprint is ultimately much bigger than it was originally, although it’s now flatter."

Intralesional injection of 5-fluorouracil can be used alone or with admixed steroids. However, Dr. Baldwin said that in her hands, the combination has been disappointing, perhaps because the triamcinolone is diluted in the process. "So I’ve reconsidered recently the possibility of doing the steroids the way I like it and following [with 5-fluoruracil] in addition to it, rather than diluting my triamcinolone," she said.

The newest nonsurgical therapy is intralesional cryotherapy, whereby the keloid is frozen from the inside out with a probe attached to a cryotherapy device, so it eventually undergoes necrosis while the skin is preserved. The reduction in volume achieved has ranged from 51% to 93% across studies, with minimal to no hypopigmentation.

"The probe itself unfortunately costs $450 and is not reusable, which is a problem. At the present time this is not covered by insurance," said Dr. Baldwin, who disclosed no relevant conflicts of interest. "But for keloids that really can’t be treated any other way, it has been quite helpful."

The meeting was presented by the Caribbean Dermatology Symposium.

sknews@frontlinemedcom.com

WOODINVILLE, WASH. – Make decisions about whether to surgically or medically manage keloids according to features of the lesion and patient-related factors, especially likely treatment compliance, Dr. Hilary E. Baldwin advised.

"Step one when we are dealing with our patients with keloids is trying to decide what the patients actually hope for," Dr. Baldwin said at the annual Coastal Dermatology Symposium. That might be eradication of the keloid; palliation of symptoms such as itching or pain; flattening, lightening, or softening of the keloid; ability to wear clip-on earrings; or restoration of mobility.

"Most patients, in my opinion, are actually not surgical candidates, and most need to be convinced to pursue other options," said Dr. Baldwin of the dermatology department at the State University of New York, Brooklyn.

Surgical management

Size and shape should factor into decisions about surgical removal of keloids, said Dr. Baldwin. Larger keloids are not much more difficult to remove than smaller ones, and pedunculated keloids are generally the most amenable to surgery, she noted.

Keloid age also comes into play, as the older, mature, brown lesions are less likely to recur after surgery than the younger, pink, symptomatic ones. Location affects outcome as well, Dr. Baldwin said. Keloids on the jaw, the deltoid, mid-back, mid-chest, and upper back are most likely to recur if treated surgically, and those in low-tension areas are less likely to do so.

Surgery also may be considered for keloids that are truly unresponsive to intralesional corticosteroids, but those are uncommon as previous lack of response is usually because of an inadequate dose, Dr. Baldwin explained.

"Most important is patient commitment. They often believe that cutting is a quick fix and they are not going to have to do anything afterward, and they are poor flight risks because of that," she said. Statistics suggest that the nearly 100% of keloids recur with surgery alone, but the value falls to 50% with adjunctive corticosteroids, and 20% with adjunctive radiation therapy, she added.

Adjunctive therapies

When adjunctive corticosteroids are used after surgery, the steroid is injected into the base and walls of the excision site, according to Dr. Baldwin; her preference is to use 40 mg/cc triamcinolone, with injections given for at least 6 months.

"Radiation therapy ... works really well postop; in fact, it’s our best adjunctive therapy, if you’re not afraid of it and the patient’s not afraid of it," she said. At her institution, this therapy is completed within a week after surgery, "so even if patients are a flight risk, they always return for that first visit, and then they are done with at least one adjunctive therapy."

The main barrier to use has been a fear of secondary malignancy. But reports of cancer after radiation therapy are rare and questionably associated with the treatment, Dr. Baldwin said.

Pressure dressings also are effective, and these are most practical in the form of compression earrings worn after excision of earlobe keloids, usually for at least 6 months. The earrings also come in a form called "sleepers" that may be more acceptable to patients.

Interferon injections also can help prevent recurrence. "I treat the very first day ... into the wall and into the base, just as I would with steroids, and then repeat 1 week later," Dr. Baldwin explained. "So if you use this and radiation therapy, 1 week later, you have finished two adjunctive therapies."

Especially challenging are keloids nearly obliterating normal tissue, such as extensive earlobe keloids. "I call them last-chance keloids," Dr. Baldwin commented. "If I don’t do a good job and don’t have good adjunctive therapy, it’s going to regrow and that’s the last time I am going to be able to cut. The earlobe will be eaten away with keloid, and we are never going to be able to give [the patient] an earlobe on which to hang an earring."

After excision of last-chance keloids, "I recommend that you do everything ... Use everything that is available to you," Dr. Baldwin advised. In addition to excision, that includes "intralesional steroids, intralesional interferon, radiation therapy, and earrings. Why pick one? Use them all if appropriate, and you are much less likely to have a recurrence," she said.

Medical management

Medical therapy is indicated for large, sessile keloids and for those located in areas where surgery could lead to complications, according to Dr. Baldwin.

In these cases, intralesional corticosteroids are the mainstay, and her preference is to use a high dose of triamcinolone. "I only use 40 [mg/cc]—that’s it. I never use anything less," she said. "I don’t care where the keloid is: A keloid on the face is the same as a keloid on the back. Most of the failures that I see are due to inadequate concentration. It’s almost always on the face where people are a little bit shy about using the extraordinarily high doses," she added.

Dr. Baldwin dismissed the dogma of not exceeding 40 mg per month, given that this translates to a dose of just 50 mg of prednisone. "I will sometimes use 80 [mg] in one sitting. I don’t really have that kind of a restriction because it doesn’t make a ton of sense," she said.

For pre-injection anesthesia, Dr. Baldwin recommended applying topical anesthetic followed by a lidocaine ring block. When treating hard keloids, to prevent backwash of the corticosteroid along the needle track, she said she preapplies Krazy Glue and, immediately after removing the needle, applies a strip of precut tape.

Patients should be advised of the possible complications of hypopigmentation, telangiectasia, and atrophy. "You also have to warn your patients about what I call the Play-Doh effect," whereby the keloid spreads as it softens, Dr. Baldwin said. "So the footprint is ultimately much bigger than it was originally, although it’s now flatter."

Intralesional injection of 5-fluorouracil can be used alone or with admixed steroids. However, Dr. Baldwin said that in her hands, the combination has been disappointing, perhaps because the triamcinolone is diluted in the process. "So I’ve reconsidered recently the possibility of doing the steroids the way I like it and following [with 5-fluoruracil] in addition to it, rather than diluting my triamcinolone," she said.

The newest nonsurgical therapy is intralesional cryotherapy, whereby the keloid is frozen from the inside out with a probe attached to a cryotherapy device, so it eventually undergoes necrosis while the skin is preserved. The reduction in volume achieved has ranged from 51% to 93% across studies, with minimal to no hypopigmentation.

"The probe itself unfortunately costs $450 and is not reusable, which is a problem. At the present time this is not covered by insurance," said Dr. Baldwin, who disclosed no relevant conflicts of interest. "But for keloids that really can’t be treated any other way, it has been quite helpful."

The meeting was presented by the Caribbean Dermatology Symposium.

sknews@frontlinemedcom.com

WOODINVILLE, WASH. – Make decisions about whether to surgically or medically manage keloids according to features of the lesion and patient-related factors, especially likely treatment compliance, Dr. Hilary E. Baldwin advised.

"Step one when we are dealing with our patients with keloids is trying to decide what the patients actually hope for," Dr. Baldwin said at the annual Coastal Dermatology Symposium. That might be eradication of the keloid; palliation of symptoms such as itching or pain; flattening, lightening, or softening of the keloid; ability to wear clip-on earrings; or restoration of mobility.

"Most patients, in my opinion, are actually not surgical candidates, and most need to be convinced to pursue other options," said Dr. Baldwin of the dermatology department at the State University of New York, Brooklyn.

Surgical management

Size and shape should factor into decisions about surgical removal of keloids, said Dr. Baldwin. Larger keloids are not much more difficult to remove than smaller ones, and pedunculated keloids are generally the most amenable to surgery, she noted.

Keloid age also comes into play, as the older, mature, brown lesions are less likely to recur after surgery than the younger, pink, symptomatic ones. Location affects outcome as well, Dr. Baldwin said. Keloids on the jaw, the deltoid, mid-back, mid-chest, and upper back are most likely to recur if treated surgically, and those in low-tension areas are less likely to do so.

Surgery also may be considered for keloids that are truly unresponsive to intralesional corticosteroids, but those are uncommon as previous lack of response is usually because of an inadequate dose, Dr. Baldwin explained.

"Most important is patient commitment. They often believe that cutting is a quick fix and they are not going to have to do anything afterward, and they are poor flight risks because of that," she said. Statistics suggest that the nearly 100% of keloids recur with surgery alone, but the value falls to 50% with adjunctive corticosteroids, and 20% with adjunctive radiation therapy, she added.

Adjunctive therapies

When adjunctive corticosteroids are used after surgery, the steroid is injected into the base and walls of the excision site, according to Dr. Baldwin; her preference is to use 40 mg/cc triamcinolone, with injections given for at least 6 months.

"Radiation therapy ... works really well postop; in fact, it’s our best adjunctive therapy, if you’re not afraid of it and the patient’s not afraid of it," she said. At her institution, this therapy is completed within a week after surgery, "so even if patients are a flight risk, they always return for that first visit, and then they are done with at least one adjunctive therapy."

The main barrier to use has been a fear of secondary malignancy. But reports of cancer after radiation therapy are rare and questionably associated with the treatment, Dr. Baldwin said.

Pressure dressings also are effective, and these are most practical in the form of compression earrings worn after excision of earlobe keloids, usually for at least 6 months. The earrings also come in a form called "sleepers" that may be more acceptable to patients.

Interferon injections also can help prevent recurrence. "I treat the very first day ... into the wall and into the base, just as I would with steroids, and then repeat 1 week later," Dr. Baldwin explained. "So if you use this and radiation therapy, 1 week later, you have finished two adjunctive therapies."

Especially challenging are keloids nearly obliterating normal tissue, such as extensive earlobe keloids. "I call them last-chance keloids," Dr. Baldwin commented. "If I don’t do a good job and don’t have good adjunctive therapy, it’s going to regrow and that’s the last time I am going to be able to cut. The earlobe will be eaten away with keloid, and we are never going to be able to give [the patient] an earlobe on which to hang an earring."

After excision of last-chance keloids, "I recommend that you do everything ... Use everything that is available to you," Dr. Baldwin advised. In addition to excision, that includes "intralesional steroids, intralesional interferon, radiation therapy, and earrings. Why pick one? Use them all if appropriate, and you are much less likely to have a recurrence," she said.

Medical management

Medical therapy is indicated for large, sessile keloids and for those located in areas where surgery could lead to complications, according to Dr. Baldwin.

In these cases, intralesional corticosteroids are the mainstay, and her preference is to use a high dose of triamcinolone. "I only use 40 [mg/cc]—that’s it. I never use anything less," she said. "I don’t care where the keloid is: A keloid on the face is the same as a keloid on the back. Most of the failures that I see are due to inadequate concentration. It’s almost always on the face where people are a little bit shy about using the extraordinarily high doses," she added.

Dr. Baldwin dismissed the dogma of not exceeding 40 mg per month, given that this translates to a dose of just 50 mg of prednisone. "I will sometimes use 80 [mg] in one sitting. I don’t really have that kind of a restriction because it doesn’t make a ton of sense," she said.

For pre-injection anesthesia, Dr. Baldwin recommended applying topical anesthetic followed by a lidocaine ring block. When treating hard keloids, to prevent backwash of the corticosteroid along the needle track, she said she preapplies Krazy Glue and, immediately after removing the needle, applies a strip of precut tape.

Patients should be advised of the possible complications of hypopigmentation, telangiectasia, and atrophy. "You also have to warn your patients about what I call the Play-Doh effect," whereby the keloid spreads as it softens, Dr. Baldwin said. "So the footprint is ultimately much bigger than it was originally, although it’s now flatter."

Intralesional injection of 5-fluorouracil can be used alone or with admixed steroids. However, Dr. Baldwin said that in her hands, the combination has been disappointing, perhaps because the triamcinolone is diluted in the process. "So I’ve reconsidered recently the possibility of doing the steroids the way I like it and following [with 5-fluoruracil] in addition to it, rather than diluting my triamcinolone," she said.

The newest nonsurgical therapy is intralesional cryotherapy, whereby the keloid is frozen from the inside out with a probe attached to a cryotherapy device, so it eventually undergoes necrosis while the skin is preserved. The reduction in volume achieved has ranged from 51% to 93% across studies, with minimal to no hypopigmentation.

"The probe itself unfortunately costs $450 and is not reusable, which is a problem. At the present time this is not covered by insurance," said Dr. Baldwin, who disclosed no relevant conflicts of interest. "But for keloids that really can’t be treated any other way, it has been quite helpful."

The meeting was presented by the Caribbean Dermatology Symposium.

sknews@frontlinemedcom.com

ISTANBUL – A novel form of photodynamic therapy achieved a much higher cure rate than did conventional PDT, based on a randomized controlled trial of organ transplant recipients with numerous actinic keratoses.

The novel approach combines pretreatment with ablative fractional laser resurfacing followed immediately by application of a photosensitizing agent and natural light exposure. In addition to its efficacy, the novel PDT approach was painless. Conventional PDT can be particularly painful for organ transplant recipients as they tend to have particularly thick and widespread lesions located at pain-sensitive sites including the underarms, dorsal hands, and face, Dr. Merete Haedersdal reported at the annual congress of the European Academy of Dermatology and Venereology.

"From a clinical point of view, we are struggling with these patients. ... Now we can individualize PDT. We already have a wonderful conventional PDT, but now we’re better off with these combined techniques, especially when we are going to treat larger areas as in this high-risk group of patients," said Dr. Haedersdal, professor of dermatology at the University of Copenhagen.

As a result of their long-term immunosuppressive therapy, organ transplant recipients have a 100-fold higher risk than the general population for squamous cell carcinoma. Further, their skin tumors grow aggressively; 6%-8% of organ transplant recipients die due to nonmelanoma skin cancers.

The novel PDT approach begins with ablative fractional laser resurfacing to create tiny holes in the skin, allowing increased uptake of the photosensitizer. Dr. Haedersdal and her coworkers used methyl aminolevulinate 16% cream, applied immediately after laser treatment. It takes 30 minutes to start the biochemical process of protoporphyrin-9 production, and the patient then goes outside for a full 2 hours of natural light exposure. This photoactivation period averaged 62,583 lux in the study. The patient then covers the treated area or stays inside for the rest of the day.

Dr. Haedersdal reported on 16 patients with a total of 542 actinic keratoses (AKs) on the scalp, chest, and extremities. The patients had received a donor organ a median of 14 years earlier. In each patient, four symmetrical skin areas within the same anatomic region were mapped out and randomized to receive a single treatment with either the novel laser-assisted daylight PDT, conventional PDT with a red light–emitting diode light source, PDT with daylight rather than the LED light source, or ablative fractional laser therapy alone.

The primary endpoint was the cure rate, or complete lesion response of all AKs at 3 months post treatment. The cure rate was 74% in the laser-assisted daylight PDT group compared with 50% with daylight PDT, 48% with conventional PDT, and 0 with laser-only treatment. When the analysis was restricted to the thicker, grade II and III AKs, the cure rate was 67% with the novel therapy, 50% with conventional PDT, 40% with daylight PDT, and 0 with laser-only treatment.

Median pain scores on a 0-10 visual analog scale were 0 for the areas treated with laser-assisted daylight PDT, laser only, and daylight PDT compared with 4.5 for the portion of skin targeted with conventional PDT. The key to pain-free PDT, according to Dr. Haedersdal, is to do the laser resurfacing at a very low fluence, allowing for continuous daylight photobleaching. The fractional laser therapy is delivered at a total of 5.6 mJ using 4.6 mJ per pulse, 1.15 W, a 50-microsecond pulse duration, 500 Hz, and 2.4% density using a 2,940-nm erbium laser. The laser holes are drilled into the epidermal layer, but not below the basement membrane.

Crusting and erythema developed in all PDT-treated patients but were slightly more intense in the areas treated with laser-assisted PDT. One patient in the laser-assisted PDT group had transient hypopigmentation.

Based on blinded assessments at 3 months, the laser-assisted daylight PDT areas displayed significantly greater skin smoothening and rejuvenation with less dyschromia than the other treatment zones. Cosmesis was rated "excellent" in the laser-treated zones of 10 out of 16 patients, a much higher rate than seen in the other treatment areas.

Dr. Haedersdal reported having received research grants from roughly half a dozen medical device and pharmaceutical companies.

bjancin@frontlinemedcom.com

ISTANBUL – A novel form of photodynamic therapy achieved a much higher cure rate than did conventional PDT, based on a randomized controlled trial of organ transplant recipients with numerous actinic keratoses.

The novel approach combines pretreatment with ablative fractional laser resurfacing followed immediately by application of a photosensitizing agent and natural light exposure. In addition to its efficacy, the novel PDT approach was painless. Conventional PDT can be particularly painful for organ transplant recipients as they tend to have particularly thick and widespread lesions located at pain-sensitive sites including the underarms, dorsal hands, and face, Dr. Merete Haedersdal reported at the annual congress of the European Academy of Dermatology and Venereology.

"From a clinical point of view, we are struggling with these patients. ... Now we can individualize PDT. We already have a wonderful conventional PDT, but now we’re better off with these combined techniques, especially when we are going to treat larger areas as in this high-risk group of patients," said Dr. Haedersdal, professor of dermatology at the University of Copenhagen.

As a result of their long-term immunosuppressive therapy, organ transplant recipients have a 100-fold higher risk than the general population for squamous cell carcinoma. Further, their skin tumors grow aggressively; 6%-8% of organ transplant recipients die due to nonmelanoma skin cancers.

The novel PDT approach begins with ablative fractional laser resurfacing to create tiny holes in the skin, allowing increased uptake of the photosensitizer. Dr. Haedersdal and her coworkers used methyl aminolevulinate 16% cream, applied immediately after laser treatment. It takes 30 minutes to start the biochemical process of protoporphyrin-9 production, and the patient then goes outside for a full 2 hours of natural light exposure. This photoactivation period averaged 62,583 lux in the study. The patient then covers the treated area or stays inside for the rest of the day.

Dr. Haedersdal reported on 16 patients with a total of 542 actinic keratoses (AKs) on the scalp, chest, and extremities. The patients had received a donor organ a median of 14 years earlier. In each patient, four symmetrical skin areas within the same anatomic region were mapped out and randomized to receive a single treatment with either the novel laser-assisted daylight PDT, conventional PDT with a red light–emitting diode light source, PDT with daylight rather than the LED light source, or ablative fractional laser therapy alone.

The primary endpoint was the cure rate, or complete lesion response of all AKs at 3 months post treatment. The cure rate was 74% in the laser-assisted daylight PDT group compared with 50% with daylight PDT, 48% with conventional PDT, and 0 with laser-only treatment. When the analysis was restricted to the thicker, grade II and III AKs, the cure rate was 67% with the novel therapy, 50% with conventional PDT, 40% with daylight PDT, and 0 with laser-only treatment.

Median pain scores on a 0-10 visual analog scale were 0 for the areas treated with laser-assisted daylight PDT, laser only, and daylight PDT compared with 4.5 for the portion of skin targeted with conventional PDT. The key to pain-free PDT, according to Dr. Haedersdal, is to do the laser resurfacing at a very low fluence, allowing for continuous daylight photobleaching. The fractional laser therapy is delivered at a total of 5.6 mJ using 4.6 mJ per pulse, 1.15 W, a 50-microsecond pulse duration, 500 Hz, and 2.4% density using a 2,940-nm erbium laser. The laser holes are drilled into the epidermal layer, but not below the basement membrane.

Crusting and erythema developed in all PDT-treated patients but were slightly more intense in the areas treated with laser-assisted PDT. One patient in the laser-assisted PDT group had transient hypopigmentation.

Based on blinded assessments at 3 months, the laser-assisted daylight PDT areas displayed significantly greater skin smoothening and rejuvenation with less dyschromia than the other treatment zones. Cosmesis was rated "excellent" in the laser-treated zones of 10 out of 16 patients, a much higher rate than seen in the other treatment areas.

Dr. Haedersdal reported having received research grants from roughly half a dozen medical device and pharmaceutical companies.

bjancin@frontlinemedcom.com

ISTANBUL – A novel form of photodynamic therapy achieved a much higher cure rate than did conventional PDT, based on a randomized controlled trial of organ transplant recipients with numerous actinic keratoses.

The novel approach combines pretreatment with ablative fractional laser resurfacing followed immediately by application of a photosensitizing agent and natural light exposure. In addition to its efficacy, the novel PDT approach was painless. Conventional PDT can be particularly painful for organ transplant recipients as they tend to have particularly thick and widespread lesions located at pain-sensitive sites including the underarms, dorsal hands, and face, Dr. Merete Haedersdal reported at the annual congress of the European Academy of Dermatology and Venereology.

"From a clinical point of view, we are struggling with these patients. ... Now we can individualize PDT. We already have a wonderful conventional PDT, but now we’re better off with these combined techniques, especially when we are going to treat larger areas as in this high-risk group of patients," said Dr. Haedersdal, professor of dermatology at the University of Copenhagen.

As a result of their long-term immunosuppressive therapy, organ transplant recipients have a 100-fold higher risk than the general population for squamous cell carcinoma. Further, their skin tumors grow aggressively; 6%-8% of organ transplant recipients die due to nonmelanoma skin cancers.

The novel PDT approach begins with ablative fractional laser resurfacing to create tiny holes in the skin, allowing increased uptake of the photosensitizer. Dr. Haedersdal and her coworkers used methyl aminolevulinate 16% cream, applied immediately after laser treatment. It takes 30 minutes to start the biochemical process of protoporphyrin-9 production, and the patient then goes outside for a full 2 hours of natural light exposure. This photoactivation period averaged 62,583 lux in the study. The patient then covers the treated area or stays inside for the rest of the day.

Dr. Haedersdal reported on 16 patients with a total of 542 actinic keratoses (AKs) on the scalp, chest, and extremities. The patients had received a donor organ a median of 14 years earlier. In each patient, four symmetrical skin areas within the same anatomic region were mapped out and randomized to receive a single treatment with either the novel laser-assisted daylight PDT, conventional PDT with a red light–emitting diode light source, PDT with daylight rather than the LED light source, or ablative fractional laser therapy alone.

The primary endpoint was the cure rate, or complete lesion response of all AKs at 3 months post treatment. The cure rate was 74% in the laser-assisted daylight PDT group compared with 50% with daylight PDT, 48% with conventional PDT, and 0 with laser-only treatment. When the analysis was restricted to the thicker, grade II and III AKs, the cure rate was 67% with the novel therapy, 50% with conventional PDT, 40% with daylight PDT, and 0 with laser-only treatment.

Median pain scores on a 0-10 visual analog scale were 0 for the areas treated with laser-assisted daylight PDT, laser only, and daylight PDT compared with 4.5 for the portion of skin targeted with conventional PDT. The key to pain-free PDT, according to Dr. Haedersdal, is to do the laser resurfacing at a very low fluence, allowing for continuous daylight photobleaching. The fractional laser therapy is delivered at a total of 5.6 mJ using 4.6 mJ per pulse, 1.15 W, a 50-microsecond pulse duration, 500 Hz, and 2.4% density using a 2,940-nm erbium laser. The laser holes are drilled into the epidermal layer, but not below the basement membrane.

Crusting and erythema developed in all PDT-treated patients but were slightly more intense in the areas treated with laser-assisted PDT. One patient in the laser-assisted PDT group had transient hypopigmentation.

Based on blinded assessments at 3 months, the laser-assisted daylight PDT areas displayed significantly greater skin smoothening and rejuvenation with less dyschromia than the other treatment zones. Cosmesis was rated "excellent" in the laser-treated zones of 10 out of 16 patients, a much higher rate than seen in the other treatment areas.

Dr. Haedersdal reported having received research grants from roughly half a dozen medical device and pharmaceutical companies.

bjancin@frontlinemedcom.com

To improve patient care and outcomes, leading dermatologists offered their recommendations on the top shampoos and conditioners. Consideration must be given to:

Cutis invites readers to send us their recommendations. Facial moisturizers, scar treatments, and over-the-counter antifungals will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to msteiger@frontlinemedcom.com.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on the top shampoos and conditioners. Consideration must be given to:

Cutis invites readers to send us their recommendations. Facial moisturizers, scar treatments, and over-the-counter antifungals will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to msteiger@frontlinemedcom.com.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on the top shampoos and conditioners. Consideration must be given to:

Cutis invites readers to send us their recommendations. Facial moisturizers, scar treatments, and over-the-counter antifungals will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to msteiger@frontlinemedcom.com.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

Litigation concerning cutaneous laser surgery has surged in recent years, and the proportion involving nonphysician operators soared from 36% in 1999 to 78% in 2012, according to a report published online Oct. 16 in JAMA Dermatology.

For the most commonly performed laser procedure – hair removal – the proportion of lawsuits involving nonphysician operators is even higher. A "remarkable" 91% of the cases filed in the most recent year for which complete data are available were brought against nonphysician operators, said Dr. H. Ray Jalian of the division of dermatology, University of California, Los Angeles, and his associates.

"The overall trend in increased litigation for laser surgery is in part explained by greater numbers of nonphysician operators performing these procedures, in particular those practicing without direct supervision in ‘medical spas,’ " the investigators said.

Dr. Jalian and his colleagues searched a single legal database and identified 175 cases concerning injury arising from cutaneous laser surgery since 1999. Nonphysician operators included registered nurses, nurse practitioners, medical assistants, electrologists, technicians, aestheticians, and others.

Overall, nonphysician operators were sued in 43% of all cases. But this total is somewhat misleading, because that percentage has risen markedly over time. It represented 78% of all cases in 2011 and both of the two cases filed in early 2012.

Hair removal was the most frequent laser procedure involved in litigation. A total of 76% of the cases brought for hair removal–associated injury in 2004-2012 involved nonphysician operators. Again, this number is markedly higher when the data are categorized by time period: 86% of all lawsuits in 2008-2012 and 91% of all lawsuits in 2010-2012 involved nonphysicians performing laser hair removal.

When the data were analyzed by the location where laser procedures took place, the majority (64%) of cases involving nonphysician operators occurred at facilities such as spas and salons. Again, in more recent years (2008-2012), "nonphysician-operator procedures performed in ‘medical spas’ represented 77% of lawsuits," Dr. Jalian and his associates said (JAMA Dermatology 2013 Oct. 16 [doi:10.1001/jamadermatol.2013. 7117]).

Clinicians also should be aware that almost all the malpractice cases arising from nonphysician operators’ negligence extend beyond the operator to his or her employer, be that a physician, a medical facility, or a spa.

By far the most common allegation against physicians was failure to supervise a nonphysician operator (27 cases), followed by failure to train or hire appropriate staff (23 cases).

The investigators noted that "the actual data likely understate the true incidence of nonphysician operator laser complications" since they were culled from the large legal database that excluded complaints that were handled outside the judicial system.

Laws regulating the use of cutaneous lasers vary widely by state, from edicts specifying that only physicians may operate lasers for hair removal (Maine) to no regulations at all on laser use (Nevada). Even when clinicians supervise so-called physician extenders, rules concerning the degree of supervision, protocol requirements, and employee training are ambiguous.

"Because laws and regulations are constantly evolving, it is imperative for [those] who use physician extenders to be up to date," the researchers said.

Dr. Jalian reported no relevant financial conflicts of interest. One of his associates reported ties to Zeltiq Aesthetics, Cytrellis Biosystems, Unilever, and Allergan.

Litigation concerning cutaneous laser surgery has surged in recent years, and the proportion involving nonphysician operators soared from 36% in 1999 to 78% in 2012, according to a report published online Oct. 16 in JAMA Dermatology.

For the most commonly performed laser procedure – hair removal – the proportion of lawsuits involving nonphysician operators is even higher. A "remarkable" 91% of the cases filed in the most recent year for which complete data are available were brought against nonphysician operators, said Dr. H. Ray Jalian of the division of dermatology, University of California, Los Angeles, and his associates.

"The overall trend in increased litigation for laser surgery is in part explained by greater numbers of nonphysician operators performing these procedures, in particular those practicing without direct supervision in ‘medical spas,’ " the investigators said.

Dr. Jalian and his colleagues searched a single legal database and identified 175 cases concerning injury arising from cutaneous laser surgery since 1999. Nonphysician operators included registered nurses, nurse practitioners, medical assistants, electrologists, technicians, aestheticians, and others.

Overall, nonphysician operators were sued in 43% of all cases. But this total is somewhat misleading, because that percentage has risen markedly over time. It represented 78% of all cases in 2011 and both of the two cases filed in early 2012.

Hair removal was the most frequent laser procedure involved in litigation. A total of 76% of the cases brought for hair removal–associated injury in 2004-2012 involved nonphysician operators. Again, this number is markedly higher when the data are categorized by time period: 86% of all lawsuits in 2008-2012 and 91% of all lawsuits in 2010-2012 involved nonphysicians performing laser hair removal.

When the data were analyzed by the location where laser procedures took place, the majority (64%) of cases involving nonphysician operators occurred at facilities such as spas and salons. Again, in more recent years (2008-2012), "nonphysician-operator procedures performed in ‘medical spas’ represented 77% of lawsuits," Dr. Jalian and his associates said (JAMA Dermatology 2013 Oct. 16 [doi:10.1001/jamadermatol.2013. 7117]).

Clinicians also should be aware that almost all the malpractice cases arising from nonphysician operators’ negligence extend beyond the operator to his or her employer, be that a physician, a medical facility, or a spa.

By far the most common allegation against physicians was failure to supervise a nonphysician operator (27 cases), followed by failure to train or hire appropriate staff (23 cases).

The investigators noted that "the actual data likely understate the true incidence of nonphysician operator laser complications" since they were culled from the large legal database that excluded complaints that were handled outside the judicial system.

Laws regulating the use of cutaneous lasers vary widely by state, from edicts specifying that only physicians may operate lasers for hair removal (Maine) to no regulations at all on laser use (Nevada). Even when clinicians supervise so-called physician extenders, rules concerning the degree of supervision, protocol requirements, and employee training are ambiguous.

"Because laws and regulations are constantly evolving, it is imperative for [those] who use physician extenders to be up to date," the researchers said.

Dr. Jalian reported no relevant financial conflicts of interest. One of his associates reported ties to Zeltiq Aesthetics, Cytrellis Biosystems, Unilever, and Allergan.

Litigation concerning cutaneous laser surgery has surged in recent years, and the proportion involving nonphysician operators soared from 36% in 1999 to 78% in 2012, according to a report published online Oct. 16 in JAMA Dermatology.

For the most commonly performed laser procedure – hair removal – the proportion of lawsuits involving nonphysician operators is even higher. A "remarkable" 91% of the cases filed in the most recent year for which complete data are available were brought against nonphysician operators, said Dr. H. Ray Jalian of the division of dermatology, University of California, Los Angeles, and his associates.

"The overall trend in increased litigation for laser surgery is in part explained by greater numbers of nonphysician operators performing these procedures, in particular those practicing without direct supervision in ‘medical spas,’ " the investigators said.

Dr. Jalian and his colleagues searched a single legal database and identified 175 cases concerning injury arising from cutaneous laser surgery since 1999. Nonphysician operators included registered nurses, nurse practitioners, medical assistants, electrologists, technicians, aestheticians, and others.

Overall, nonphysician operators were sued in 43% of all cases. But this total is somewhat misleading, because that percentage has risen markedly over time. It represented 78% of all cases in 2011 and both of the two cases filed in early 2012.

Hair removal was the most frequent laser procedure involved in litigation. A total of 76% of the cases brought for hair removal–associated injury in 2004-2012 involved nonphysician operators. Again, this number is markedly higher when the data are categorized by time period: 86% of all lawsuits in 2008-2012 and 91% of all lawsuits in 2010-2012 involved nonphysicians performing laser hair removal.

When the data were analyzed by the location where laser procedures took place, the majority (64%) of cases involving nonphysician operators occurred at facilities such as spas and salons. Again, in more recent years (2008-2012), "nonphysician-operator procedures performed in ‘medical spas’ represented 77% of lawsuits," Dr. Jalian and his associates said (JAMA Dermatology 2013 Oct. 16 [doi:10.1001/jamadermatol.2013. 7117]).

Clinicians also should be aware that almost all the malpractice cases arising from nonphysician operators’ negligence extend beyond the operator to his or her employer, be that a physician, a medical facility, or a spa.

By far the most common allegation against physicians was failure to supervise a nonphysician operator (27 cases), followed by failure to train or hire appropriate staff (23 cases).

The investigators noted that "the actual data likely understate the true incidence of nonphysician operator laser complications" since they were culled from the large legal database that excluded complaints that were handled outside the judicial system.

Laws regulating the use of cutaneous lasers vary widely by state, from edicts specifying that only physicians may operate lasers for hair removal (Maine) to no regulations at all on laser use (Nevada). Even when clinicians supervise so-called physician extenders, rules concerning the degree of supervision, protocol requirements, and employee training are ambiguous.

"Because laws and regulations are constantly evolving, it is imperative for [those] who use physician extenders to be up to date," the researchers said.

Dr. Jalian reported no relevant financial conflicts of interest. One of his associates reported ties to Zeltiq Aesthetics, Cytrellis Biosystems, Unilever, and Allergan.