Aesthetic Dermatology

SAN FRANCISCO — Growth hormone therapy might help adults with a deficiency, but there's no evidence that it helps normal elderly adults or athletes.

Illegal use in antiaging clinics probably accounts for the largest use of growth hormone in the United States today, Dr. Andrew R. Hoffman said.

The therapy is indicated for adults for the treatment of growth hormone deficiency caused by pituitary disease, hypothalamic disease, surgery, radiation, or trauma. It is the only drug in the U.S. that cannot legally be prescribed off label, he said at a meeting on diabetes and endocrinology sponsored by the University of California, San Francisco.

What's more, its use in normal elderly people may cause harm by inducing glucose intolerance or increasing the risk for cancer, “although we do not know that” for sure, said Dr. Hoffman, professor of medicine at Stanford (Calif.) University and the Veterans Affairs Palo Alto Health Care System.

Interest in treating normal age-related declines in growth hormone secretion and insulin-like growth factor 1 (IGF-1)—dubbed the “somatopause”—zoomed after a 1999 study reported that giving growth hormone injections to male veterans aged older than 60 years for 6 months increased lean tissue mass by 9%, skin thickness by 7%, and lower-back vertebral density by 2%, while decreasing fatty tissue by 14% (N. Engl. J. Med. 1990;323:1-6). The authors described the effects as equivalent in magnitude to the changes that occur during 10-20 years of aging. “This set up a lot of excitement and was the basis for all the antiaging clinics you can find,” Dr. Hoffman said.

It also generated multiple animal studies by the National Institutes of Health, every one of which showed that longevity is associated with lower growth hormone levels, not higher ones. A systematic review of randomized, controlled trials of growth hormone injections in healthy elderly humans reported small changes in body composition and high rates of adverse events (Ann. Intern. Med. 2007;146:104-15).

One of the potential side effects with growth hormone overtreatment is increased edema. “You can't say it increases muscle,” Dr. Hoffman said. “Much of it might be fluid retention.”

The medical literature suggests that treatment probably is helpful for patients with growth hormone deficiency syndrome, Dr. Hoffman said. Treatment produces significant and durable changes in cardiac effects. Bodily fat mass, LDL cholesterol, and total cholesterol levels decrease but insulin and glucose levels tend to increase.

In general, patients treated for growth hormone deficiency syndrome become more physically active, increase their strength and exercise capacity, and slightly increase bone mineral density.

Other data suggest, however, that high levels of IGF-1 over long periods of time could increase the risk for prostate cancer or premenopausal breast cancer.

Dr. Hoffman has received research support, owned stock, or been a consultant to companies that market growth hormone or related products, including Ambryx, LG Life Science, Tercica, Merck Serono, Pfizer, Novo Nordisk, and Teva Pharmaceutical Industries.

SAN FRANCISCO — Growth hormone therapy might help adults with a deficiency, but there's no evidence that it helps normal elderly adults or athletes.

Illegal use in antiaging clinics probably accounts for the largest use of growth hormone in the United States today, Dr. Andrew R. Hoffman said.

The therapy is indicated for adults for the treatment of growth hormone deficiency caused by pituitary disease, hypothalamic disease, surgery, radiation, or trauma. It is the only drug in the U.S. that cannot legally be prescribed off label, he said at a meeting on diabetes and endocrinology sponsored by the University of California, San Francisco.

What's more, its use in normal elderly people may cause harm by inducing glucose intolerance or increasing the risk for cancer, “although we do not know that” for sure, said Dr. Hoffman, professor of medicine at Stanford (Calif.) University and the Veterans Affairs Palo Alto Health Care System.

Interest in treating normal age-related declines in growth hormone secretion and insulin-like growth factor 1 (IGF-1)—dubbed the “somatopause”—zoomed after a 1999 study reported that giving growth hormone injections to male veterans aged older than 60 years for 6 months increased lean tissue mass by 9%, skin thickness by 7%, and lower-back vertebral density by 2%, while decreasing fatty tissue by 14% (N. Engl. J. Med. 1990;323:1-6). The authors described the effects as equivalent in magnitude to the changes that occur during 10-20 years of aging. “This set up a lot of excitement and was the basis for all the antiaging clinics you can find,” Dr. Hoffman said.

It also generated multiple animal studies by the National Institutes of Health, every one of which showed that longevity is associated with lower growth hormone levels, not higher ones. A systematic review of randomized, controlled trials of growth hormone injections in healthy elderly humans reported small changes in body composition and high rates of adverse events (Ann. Intern. Med. 2007;146:104-15).

One of the potential side effects with growth hormone overtreatment is increased edema. “You can't say it increases muscle,” Dr. Hoffman said. “Much of it might be fluid retention.”

The medical literature suggests that treatment probably is helpful for patients with growth hormone deficiency syndrome, Dr. Hoffman said. Treatment produces significant and durable changes in cardiac effects. Bodily fat mass, LDL cholesterol, and total cholesterol levels decrease but insulin and glucose levels tend to increase.

In general, patients treated for growth hormone deficiency syndrome become more physically active, increase their strength and exercise capacity, and slightly increase bone mineral density.

Other data suggest, however, that high levels of IGF-1 over long periods of time could increase the risk for prostate cancer or premenopausal breast cancer.

Dr. Hoffman has received research support, owned stock, or been a consultant to companies that market growth hormone or related products, including Ambryx, LG Life Science, Tercica, Merck Serono, Pfizer, Novo Nordisk, and Teva Pharmaceutical Industries.

SAN FRANCISCO — Growth hormone therapy might help adults with a deficiency, but there's no evidence that it helps normal elderly adults or athletes.

Illegal use in antiaging clinics probably accounts for the largest use of growth hormone in the United States today, Dr. Andrew R. Hoffman said.

The therapy is indicated for adults for the treatment of growth hormone deficiency caused by pituitary disease, hypothalamic disease, surgery, radiation, or trauma. It is the only drug in the U.S. that cannot legally be prescribed off label, he said at a meeting on diabetes and endocrinology sponsored by the University of California, San Francisco.

What's more, its use in normal elderly people may cause harm by inducing glucose intolerance or increasing the risk for cancer, “although we do not know that” for sure, said Dr. Hoffman, professor of medicine at Stanford (Calif.) University and the Veterans Affairs Palo Alto Health Care System.

Interest in treating normal age-related declines in growth hormone secretion and insulin-like growth factor 1 (IGF-1)—dubbed the “somatopause”—zoomed after a 1999 study reported that giving growth hormone injections to male veterans aged older than 60 years for 6 months increased lean tissue mass by 9%, skin thickness by 7%, and lower-back vertebral density by 2%, while decreasing fatty tissue by 14% (N. Engl. J. Med. 1990;323:1-6). The authors described the effects as equivalent in magnitude to the changes that occur during 10-20 years of aging. “This set up a lot of excitement and was the basis for all the antiaging clinics you can find,” Dr. Hoffman said.

It also generated multiple animal studies by the National Institutes of Health, every one of which showed that longevity is associated with lower growth hormone levels, not higher ones. A systematic review of randomized, controlled trials of growth hormone injections in healthy elderly humans reported small changes in body composition and high rates of adverse events (Ann. Intern. Med. 2007;146:104-15).

One of the potential side effects with growth hormone overtreatment is increased edema. “You can't say it increases muscle,” Dr. Hoffman said. “Much of it might be fluid retention.”

The medical literature suggests that treatment probably is helpful for patients with growth hormone deficiency syndrome, Dr. Hoffman said. Treatment produces significant and durable changes in cardiac effects. Bodily fat mass, LDL cholesterol, and total cholesterol levels decrease but insulin and glucose levels tend to increase.

In general, patients treated for growth hormone deficiency syndrome become more physically active, increase their strength and exercise capacity, and slightly increase bone mineral density.

Other data suggest, however, that high levels of IGF-1 over long periods of time could increase the risk for prostate cancer or premenopausal breast cancer.

Dr. Hoffman has received research support, owned stock, or been a consultant to companies that market growth hormone or related products, including Ambryx, LG Life Science, Tercica, Merck Serono, Pfizer, Novo Nordisk, and Teva Pharmaceutical Industries.

SAN FRANCISCO — Chronic wounds due to scleroderma responded well to a combination of mesenchymal stem cells and bilayer bioengineered skin, in a study of 12 patients followed for up to 6 months.

Four wounds completely healed, and the others decreased in size enough that patients' quality of life was improved, Dr. Vincent Falanga said in a press briefing at the annual meeting of the American Academy of Dermatology.

He and his associates harvested the patients' own stem cells from a small amount of bone marrow taken from the hip. And they applied the stem cells to the wound with an innovative fibrin spray system that had not been used before in humans.

Using a pressurized double-barrel syringe, they placed the cells in fibrinogen in one barrel and in a thrombin solution in the other. This produced a fine spray, spreading the cells evenly over the wound and simultaneously combining the fibrinogen and thrombin to form fibrin, which glued the cells to the exposed wound tissue, said Dr. Falanga of Boston University and Roger Williams Medical Center, Providence, R.I.

In prior studies, Dr. Falanga determined that the spray alone would not be enough to encourage the stem cells to differentiate into skin cells. To teach the stem cells to become skin cells, he covered the spray with living bioengineered skin substitute, specifically a product from Organogenesis Inc. called Apligraf that contains two layers of living cells, one of fibroblasts and one of keratinocytes.

Dr. Falanga gave each patient three treatments, the maximum permitted by the Food and Drug Administration. He said that he thinks the patients would do even better with additional treatments and hopes to receive approval for this as his studies continue.

Dr. Falanga said he found it necessary to use quite a large number of stem cells, 1.5 million to 2 million/cm

He continued, “I think that this is a lesson that's going to be learned when we go into other areas of medicine. Whether it's skin, brain, spinal cord, we have to have some methods whereby we impart upon the stem cells a didactic component, a direction we want them to go to.”

Dr. Falanga disclosed that he is a former consultant to the company Organogenesis.

SAN FRANCISCO — Chronic wounds due to scleroderma responded well to a combination of mesenchymal stem cells and bilayer bioengineered skin, in a study of 12 patients followed for up to 6 months.

Four wounds completely healed, and the others decreased in size enough that patients' quality of life was improved, Dr. Vincent Falanga said in a press briefing at the annual meeting of the American Academy of Dermatology.

He and his associates harvested the patients' own stem cells from a small amount of bone marrow taken from the hip. And they applied the stem cells to the wound with an innovative fibrin spray system that had not been used before in humans.

Using a pressurized double-barrel syringe, they placed the cells in fibrinogen in one barrel and in a thrombin solution in the other. This produced a fine spray, spreading the cells evenly over the wound and simultaneously combining the fibrinogen and thrombin to form fibrin, which glued the cells to the exposed wound tissue, said Dr. Falanga of Boston University and Roger Williams Medical Center, Providence, R.I.

In prior studies, Dr. Falanga determined that the spray alone would not be enough to encourage the stem cells to differentiate into skin cells. To teach the stem cells to become skin cells, he covered the spray with living bioengineered skin substitute, specifically a product from Organogenesis Inc. called Apligraf that contains two layers of living cells, one of fibroblasts and one of keratinocytes.

Dr. Falanga gave each patient three treatments, the maximum permitted by the Food and Drug Administration. He said that he thinks the patients would do even better with additional treatments and hopes to receive approval for this as his studies continue.

Dr. Falanga said he found it necessary to use quite a large number of stem cells, 1.5 million to 2 million/cm

He continued, “I think that this is a lesson that's going to be learned when we go into other areas of medicine. Whether it's skin, brain, spinal cord, we have to have some methods whereby we impart upon the stem cells a didactic component, a direction we want them to go to.”

Dr. Falanga disclosed that he is a former consultant to the company Organogenesis.

SAN FRANCISCO — Chronic wounds due to scleroderma responded well to a combination of mesenchymal stem cells and bilayer bioengineered skin, in a study of 12 patients followed for up to 6 months.

Four wounds completely healed, and the others decreased in size enough that patients' quality of life was improved, Dr. Vincent Falanga said in a press briefing at the annual meeting of the American Academy of Dermatology.

He and his associates harvested the patients' own stem cells from a small amount of bone marrow taken from the hip. And they applied the stem cells to the wound with an innovative fibrin spray system that had not been used before in humans.

Using a pressurized double-barrel syringe, they placed the cells in fibrinogen in one barrel and in a thrombin solution in the other. This produced a fine spray, spreading the cells evenly over the wound and simultaneously combining the fibrinogen and thrombin to form fibrin, which glued the cells to the exposed wound tissue, said Dr. Falanga of Boston University and Roger Williams Medical Center, Providence, R.I.

In prior studies, Dr. Falanga determined that the spray alone would not be enough to encourage the stem cells to differentiate into skin cells. To teach the stem cells to become skin cells, he covered the spray with living bioengineered skin substitute, specifically a product from Organogenesis Inc. called Apligraf that contains two layers of living cells, one of fibroblasts and one of keratinocytes.

Dr. Falanga gave each patient three treatments, the maximum permitted by the Food and Drug Administration. He said that he thinks the patients would do even better with additional treatments and hopes to receive approval for this as his studies continue.

Dr. Falanga said he found it necessary to use quite a large number of stem cells, 1.5 million to 2 million/cm

He continued, “I think that this is a lesson that's going to be learned when we go into other areas of medicine. Whether it's skin, brain, spinal cord, we have to have some methods whereby we impart upon the stem cells a didactic component, a direction we want them to go to.”

Dr. Falanga disclosed that he is a former consultant to the company Organogenesis.

SCOTTSDALE, ARIZ. — Silicone or saline?

With 550,000 breast augmentations performed each year in the United States, it's a question physicians and surgeons get asked a lot.

Today, most women choose silicone. Indeed, silicone gel breast implants have dominated the marketplace since November 2006, when the Food and Drug Administration lifted its moratorium on their primary cosmetic use. Silicone gel now accounts for 56% of all breast implants; saline implants, for 44%. But many women who opt for silicone gel implants don't fully appreciate the higher long-term complication rate, one expert said at the annual meeting of the American Academy of Cosmetic Surgery.

"It's really important for these young ladies to understand what they're getting in for 10-20 years from now, because often the complications are not reversible," explained Dr. Erik J. Nuveen, an Oklahoma City cosmetic surgeon who has performed more than 4,000 breast augmentations.

Dr. Nuveen uses both silicone and saline implants. In presurgical counseling, he has witnessed how the tactile experience of handling the silicone devices in the consultation room can influence the selection. This makes it all the more critical, he stressed, that a woman fully understands the pros and cons of both implant types before making her decision.

"The silicone gel implants are softer, more natural feeling. It's alluring to place one on the table and then put it in the patient's hand. You put a saline [implant] in the other hand and, sure enough, 99% of patients say, 'I've got to get that silicone gel,'" he said.

Silicone breast implants' purported association with connective tissue diseases—the debunked controversy that prompted the former FDA moratorium—has distracted attention from other, very real problems with silicone gel implants, he said.

An estimated 45% of women receiving silicone implants undergo reoperations within 10 years. In practical terms, this means that among women receiving silicone gel breast implants this year, there will be 138,600 reoperations for device rupture, contracture, pain, or loss of shape within the coming decade.

In contrast, the 10-year reoperation rate with saline implants is 20%-26%—roughly half the rate for silicone gel implants.

"These numbers are really important to me. They directly impact how I advise patients in order to minimize complications in their lives at 10 years," Dr. Nuveen continued.

Extracapsular rupture of a silicone gel implant with resultant migration of a silicone stream is a major problem. The silicone must be surgically removed before it can reach the lungs or other vital organs—and that involves a lumpectomy or mastectomy.

The extracapsular rupture rate is 1% at the time of implantation, 7% at 5 years, and estimated at 10% at 10 years.

In contrast, rupture of a saline implant is less problematic. Implant deflation is immediately apparent, and the saline is readily absorbed by surrounding tissue. There is no need to remove substantial breast tissue. The rupture rate with saline implants is 3%-10% at 10 years, depending largely on surgeon expertise.

The reoperation rate for capsular contraction is substantially lower with saline implants than silicone gel.

Silicone gel implants require a larger placement incision—a minimum of 5 cm—because they go in full. The implants themselves are more expensive than saline ones. Moreover, silicone gel recipients have to bear a continuing lifelong expense for FDA-mandated MRI evaluation in order to detect silent rupture. The initial MRI is required at 3 years, then every 2 years thereafter. It's not covered by insurance.

MRI has an 89% sensitivity for detection of implant rupture. In contrast, physical examination of the breast has only 10%-30% sensitivity. Mammography is quite poor at detecting silicone implant rupture while it's still intracapsular and therefore far more easily treated. Moreover, mammography is the No. 1 cause of implant shell failure.

These days the clinical situation in which Dr. Nuveen said he is most comfortable in recommending silicone gel is in the thinnest patients, who are more likely to find saline implants uncomfortable.

Dr. Nuveen said the future of breast augmentation may be a highly cohesive silicone gel known as style 410. It is the most widely used type of implant in Europe but remains investigational in the United States, where large clinical trials are underway. The 3-year U.S. data are encouraging, but longer follow-up is required.

Dr. Nuveen reported having no conflicts of interest.

SCOTTSDALE, ARIZ. — Silicone or saline?

With 550,000 breast augmentations performed each year in the United States, it's a question physicians and surgeons get asked a lot.

Today, most women choose silicone. Indeed, silicone gel breast implants have dominated the marketplace since November 2006, when the Food and Drug Administration lifted its moratorium on their primary cosmetic use. Silicone gel now accounts for 56% of all breast implants; saline implants, for 44%. But many women who opt for silicone gel implants don't fully appreciate the higher long-term complication rate, one expert said at the annual meeting of the American Academy of Cosmetic Surgery.

"It's really important for these young ladies to understand what they're getting in for 10-20 years from now, because often the complications are not reversible," explained Dr. Erik J. Nuveen, an Oklahoma City cosmetic surgeon who has performed more than 4,000 breast augmentations.

Dr. Nuveen uses both silicone and saline implants. In presurgical counseling, he has witnessed how the tactile experience of handling the silicone devices in the consultation room can influence the selection. This makes it all the more critical, he stressed, that a woman fully understands the pros and cons of both implant types before making her decision.

"The silicone gel implants are softer, more natural feeling. It's alluring to place one on the table and then put it in the patient's hand. You put a saline [implant] in the other hand and, sure enough, 99% of patients say, 'I've got to get that silicone gel,'" he said.

Silicone breast implants' purported association with connective tissue diseases—the debunked controversy that prompted the former FDA moratorium—has distracted attention from other, very real problems with silicone gel implants, he said.

An estimated 45% of women receiving silicone implants undergo reoperations within 10 years. In practical terms, this means that among women receiving silicone gel breast implants this year, there will be 138,600 reoperations for device rupture, contracture, pain, or loss of shape within the coming decade.

In contrast, the 10-year reoperation rate with saline implants is 20%-26%—roughly half the rate for silicone gel implants.

"These numbers are really important to me. They directly impact how I advise patients in order to minimize complications in their lives at 10 years," Dr. Nuveen continued.

Extracapsular rupture of a silicone gel implant with resultant migration of a silicone stream is a major problem. The silicone must be surgically removed before it can reach the lungs or other vital organs—and that involves a lumpectomy or mastectomy.

The extracapsular rupture rate is 1% at the time of implantation, 7% at 5 years, and estimated at 10% at 10 years.

In contrast, rupture of a saline implant is less problematic. Implant deflation is immediately apparent, and the saline is readily absorbed by surrounding tissue. There is no need to remove substantial breast tissue. The rupture rate with saline implants is 3%-10% at 10 years, depending largely on surgeon expertise.

The reoperation rate for capsular contraction is substantially lower with saline implants than silicone gel.

Silicone gel implants require a larger placement incision—a minimum of 5 cm—because they go in full. The implants themselves are more expensive than saline ones. Moreover, silicone gel recipients have to bear a continuing lifelong expense for FDA-mandated MRI evaluation in order to detect silent rupture. The initial MRI is required at 3 years, then every 2 years thereafter. It's not covered by insurance.

MRI has an 89% sensitivity for detection of implant rupture. In contrast, physical examination of the breast has only 10%-30% sensitivity. Mammography is quite poor at detecting silicone implant rupture while it's still intracapsular and therefore far more easily treated. Moreover, mammography is the No. 1 cause of implant shell failure.

These days the clinical situation in which Dr. Nuveen said he is most comfortable in recommending silicone gel is in the thinnest patients, who are more likely to find saline implants uncomfortable.

Dr. Nuveen said the future of breast augmentation may be a highly cohesive silicone gel known as style 410. It is the most widely used type of implant in Europe but remains investigational in the United States, where large clinical trials are underway. The 3-year U.S. data are encouraging, but longer follow-up is required.

Dr. Nuveen reported having no conflicts of interest.

SCOTTSDALE, ARIZ. — Silicone or saline?

With 550,000 breast augmentations performed each year in the United States, it's a question physicians and surgeons get asked a lot.

Today, most women choose silicone. Indeed, silicone gel breast implants have dominated the marketplace since November 2006, when the Food and Drug Administration lifted its moratorium on their primary cosmetic use. Silicone gel now accounts for 56% of all breast implants; saline implants, for 44%. But many women who opt for silicone gel implants don't fully appreciate the higher long-term complication rate, one expert said at the annual meeting of the American Academy of Cosmetic Surgery.

"It's really important for these young ladies to understand what they're getting in for 10-20 years from now, because often the complications are not reversible," explained Dr. Erik J. Nuveen, an Oklahoma City cosmetic surgeon who has performed more than 4,000 breast augmentations.

Dr. Nuveen uses both silicone and saline implants. In presurgical counseling, he has witnessed how the tactile experience of handling the silicone devices in the consultation room can influence the selection. This makes it all the more critical, he stressed, that a woman fully understands the pros and cons of both implant types before making her decision.

"The silicone gel implants are softer, more natural feeling. It's alluring to place one on the table and then put it in the patient's hand. You put a saline [implant] in the other hand and, sure enough, 99% of patients say, 'I've got to get that silicone gel,'" he said.

Silicone breast implants' purported association with connective tissue diseases—the debunked controversy that prompted the former FDA moratorium—has distracted attention from other, very real problems with silicone gel implants, he said.

An estimated 45% of women receiving silicone implants undergo reoperations within 10 years. In practical terms, this means that among women receiving silicone gel breast implants this year, there will be 138,600 reoperations for device rupture, contracture, pain, or loss of shape within the coming decade.

In contrast, the 10-year reoperation rate with saline implants is 20%-26%—roughly half the rate for silicone gel implants.

"These numbers are really important to me. They directly impact how I advise patients in order to minimize complications in their lives at 10 years," Dr. Nuveen continued.

Extracapsular rupture of a silicone gel implant with resultant migration of a silicone stream is a major problem. The silicone must be surgically removed before it can reach the lungs or other vital organs—and that involves a lumpectomy or mastectomy.

The extracapsular rupture rate is 1% at the time of implantation, 7% at 5 years, and estimated at 10% at 10 years.

In contrast, rupture of a saline implant is less problematic. Implant deflation is immediately apparent, and the saline is readily absorbed by surrounding tissue. There is no need to remove substantial breast tissue. The rupture rate with saline implants is 3%-10% at 10 years, depending largely on surgeon expertise.

The reoperation rate for capsular contraction is substantially lower with saline implants than silicone gel.

Silicone gel implants require a larger placement incision—a minimum of 5 cm—because they go in full. The implants themselves are more expensive than saline ones. Moreover, silicone gel recipients have to bear a continuing lifelong expense for FDA-mandated MRI evaluation in order to detect silent rupture. The initial MRI is required at 3 years, then every 2 years thereafter. It's not covered by insurance.

MRI has an 89% sensitivity for detection of implant rupture. In contrast, physical examination of the breast has only 10%-30% sensitivity. Mammography is quite poor at detecting silicone implant rupture while it's still intracapsular and therefore far more easily treated. Moreover, mammography is the No. 1 cause of implant shell failure.

These days the clinical situation in which Dr. Nuveen said he is most comfortable in recommending silicone gel is in the thinnest patients, who are more likely to find saline implants uncomfortable.

Dr. Nuveen said the future of breast augmentation may be a highly cohesive silicone gel known as style 410. It is the most widely used type of implant in Europe but remains investigational in the United States, where large clinical trials are underway. The 3-year U.S. data are encouraging, but longer follow-up is required.

Dr. Nuveen reported having no conflicts of interest.

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

LAS VEGAS — The way Dr. Vic A. Narurkar sees it, multimodal therapy is integral to most noninvasive dermatologic treatments.

"We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "They complement each other, but we need to do controlled studies to see if there is true synergy, for example, between injectables and fractional resurfacing."

He discussed the role of multimodal therapy for treating several conditions:

▸ Acne and acne scarring. Prevention options include topical and systemic agents and devices for acute treatment. "We then can correct acne scars with Fraxel laser and injectable fillers such as Juvéderm," said Dr. Narurkar, a dermatologist who practices in San Francisco. Posttreatment acne still needs to be controlled with topical agents.

Isolaz, a device from Aesthera Corp., uses pneumatics to cleanse pores mechanically; it is cleared by the Food and Drug Administration to treat pustular and comedonal acne as well as mild to moderate acne vulgaris. "I call this dermatologic fantasy, because it's this extrusion of pores that we all strive for," said Dr. Narurkar, who is also associate professor of clinical dermatology at the University of California, Davis.

"You get mechanical cleansing by the application of gentle suction. What's interesting about this technology is that you can see immediate impact, similar to cortisone injections. If you combine it with topical retinoids and topical antibiotics, you get an even better result."

▸ Rosacea. Prevention and management options include topical agents such as azelaic acid, metronidazole or sulfur, and oral antibiotics. Treatment of diffuse and isolated telangiectasias "is most effective with the use of vascular lasers—pulsed dye or pulsed KTP [potassium-titanyl-phosphate]—or with the second- and third-generation intense pulsed light sources," he said.

▸ Melasma. Dr. Narurkar called this condition "the sin of dermatology," noting that melasma is difficult to treat and manage. "We pretreat with hydroquinones or retinoids," he said. "The only laser I'll use for therapy-resistant melasma is nonablative fractional resurfacing with the Fraxel Re:Store Laser. I haven't had success with any other laser and you can still get recurrence if it is not managed topically."

For posttreatment, he suggests hydroquinones and retinoids and daily use of a broad spectrum sunscreen. "If patients can avoid birth control pills and other estrogen agents, that's even better," he said.

▸ Skin rejuvenation. For optimal results he recommends "the four Rs": retain and replenish with skin care and sunscreen, resurface with devices, relax with botulinum toxins, and refill with dermal fillers.

Acute treatment of mild to moderate photoaging can be achieved via photofacials with pulsed light sources, vascular and pigmented lesion lasers, and mild nonablative fractional resurfacing.

Treatment of moderate to severe photoaging can be achieved with photodynamic therapy and aggressive nonablative and ablative fractional resurfacing. "For advanced photoaging, you can enhance IPL [intense-pulsed light] and PDL [pulsed dye laser] treatments with Levulan," he said. "You need fewer treatments, there are more immediate results, but there is significantly more down time."

Dr. Narurkar disclosed that he is a consultant to and has performed clinical trials for Aesthera Corp., Allergan Inc., BioForm Medical Inc., Palomar Medical Technologies Inc., and Reliant Technologies Inc.

'We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined.' DR. NARURKAR

LAS VEGAS — The way Dr. Vic A. Narurkar sees it, multimodal therapy is integral to most noninvasive dermatologic treatments.

"We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "They complement each other, but we need to do controlled studies to see if there is true synergy, for example, between injectables and fractional resurfacing."

He discussed the role of multimodal therapy for treating several conditions:

▸ Acne and acne scarring. Prevention options include topical and systemic agents and devices for acute treatment. "We then can correct acne scars with Fraxel laser and injectable fillers such as Juvéderm," said Dr. Narurkar, a dermatologist who practices in San Francisco. Posttreatment acne still needs to be controlled with topical agents.

Isolaz, a device from Aesthera Corp., uses pneumatics to cleanse pores mechanically; it is cleared by the Food and Drug Administration to treat pustular and comedonal acne as well as mild to moderate acne vulgaris. "I call this dermatologic fantasy, because it's this extrusion of pores that we all strive for," said Dr. Narurkar, who is also associate professor of clinical dermatology at the University of California, Davis.

"You get mechanical cleansing by the application of gentle suction. What's interesting about this technology is that you can see immediate impact, similar to cortisone injections. If you combine it with topical retinoids and topical antibiotics, you get an even better result."

▸ Rosacea. Prevention and management options include topical agents such as azelaic acid, metronidazole or sulfur, and oral antibiotics. Treatment of diffuse and isolated telangiectasias "is most effective with the use of vascular lasers—pulsed dye or pulsed KTP [potassium-titanyl-phosphate]—or with the second- and third-generation intense pulsed light sources," he said.

▸ Melasma. Dr. Narurkar called this condition "the sin of dermatology," noting that melasma is difficult to treat and manage. "We pretreat with hydroquinones or retinoids," he said. "The only laser I'll use for therapy-resistant melasma is nonablative fractional resurfacing with the Fraxel Re:Store Laser. I haven't had success with any other laser and you can still get recurrence if it is not managed topically."

For posttreatment, he suggests hydroquinones and retinoids and daily use of a broad spectrum sunscreen. "If patients can avoid birth control pills and other estrogen agents, that's even better," he said.

▸ Skin rejuvenation. For optimal results he recommends "the four Rs": retain and replenish with skin care and sunscreen, resurface with devices, relax with botulinum toxins, and refill with dermal fillers.

Acute treatment of mild to moderate photoaging can be achieved via photofacials with pulsed light sources, vascular and pigmented lesion lasers, and mild nonablative fractional resurfacing.

Treatment of moderate to severe photoaging can be achieved with photodynamic therapy and aggressive nonablative and ablative fractional resurfacing. "For advanced photoaging, you can enhance IPL [intense-pulsed light] and PDL [pulsed dye laser] treatments with Levulan," he said. "You need fewer treatments, there are more immediate results, but there is significantly more down time."

Dr. Narurkar disclosed that he is a consultant to and has performed clinical trials for Aesthera Corp., Allergan Inc., BioForm Medical Inc., Palomar Medical Technologies Inc., and Reliant Technologies Inc.

'We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined.' DR. NARURKAR

LAS VEGAS — The way Dr. Vic A. Narurkar sees it, multimodal therapy is integral to most noninvasive dermatologic treatments.

"We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "They complement each other, but we need to do controlled studies to see if there is true synergy, for example, between injectables and fractional resurfacing."

He discussed the role of multimodal therapy for treating several conditions:

▸ Acne and acne scarring. Prevention options include topical and systemic agents and devices for acute treatment. "We then can correct acne scars with Fraxel laser and injectable fillers such as Juvéderm," said Dr. Narurkar, a dermatologist who practices in San Francisco. Posttreatment acne still needs to be controlled with topical agents.

Isolaz, a device from Aesthera Corp., uses pneumatics to cleanse pores mechanically; it is cleared by the Food and Drug Administration to treat pustular and comedonal acne as well as mild to moderate acne vulgaris. "I call this dermatologic fantasy, because it's this extrusion of pores that we all strive for," said Dr. Narurkar, who is also associate professor of clinical dermatology at the University of California, Davis.

"You get mechanical cleansing by the application of gentle suction. What's interesting about this technology is that you can see immediate impact, similar to cortisone injections. If you combine it with topical retinoids and topical antibiotics, you get an even better result."

▸ Rosacea. Prevention and management options include topical agents such as azelaic acid, metronidazole or sulfur, and oral antibiotics. Treatment of diffuse and isolated telangiectasias "is most effective with the use of vascular lasers—pulsed dye or pulsed KTP [potassium-titanyl-phosphate]—or with the second- and third-generation intense pulsed light sources," he said.

▸ Melasma. Dr. Narurkar called this condition "the sin of dermatology," noting that melasma is difficult to treat and manage. "We pretreat with hydroquinones or retinoids," he said. "The only laser I'll use for therapy-resistant melasma is nonablative fractional resurfacing with the Fraxel Re:Store Laser. I haven't had success with any other laser and you can still get recurrence if it is not managed topically."

For posttreatment, he suggests hydroquinones and retinoids and daily use of a broad spectrum sunscreen. "If patients can avoid birth control pills and other estrogen agents, that's even better," he said.

▸ Skin rejuvenation. For optimal results he recommends "the four Rs": retain and replenish with skin care and sunscreen, resurface with devices, relax with botulinum toxins, and refill with dermal fillers.

Acute treatment of mild to moderate photoaging can be achieved via photofacials with pulsed light sources, vascular and pigmented lesion lasers, and mild nonablative fractional resurfacing.

Treatment of moderate to severe photoaging can be achieved with photodynamic therapy and aggressive nonablative and ablative fractional resurfacing. "For advanced photoaging, you can enhance IPL [intense-pulsed light] and PDL [pulsed dye laser] treatments with Levulan," he said. "You need fewer treatments, there are more immediate results, but there is significantly more down time."

Dr. Narurkar disclosed that he is a consultant to and has performed clinical trials for Aesthera Corp., Allergan Inc., BioForm Medical Inc., Palomar Medical Technologies Inc., and Reliant Technologies Inc.

'We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined.' DR. NARURKAR

MAUI, HAWAII — A key to minimizing the risk of bump and nodule formation when injecting poly-L-lactic acid is uniform product distribution by lengthening the dilution time, according to Dr. Douglas Mest.

"I will not inject PLLA if it hasn't been hydrated at least overnight. Longer is even better. The product insert allows for up to 72 hours hydration in sterile water; if you use bacteriostatic sterile water I think it's fine to keep it longer. Most experts keep it around for up to 3 weeks," Dr. Mest said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

The hydrated product can be kept in the refrigerator but should be brought to room temperature before injection. It should not be heated because that can damage the microscopic PLLA particles, according to Dr. Mest of the Blue Pacific Aesthetic Medical Group, El Segundo, Calif.

Other tips he offered to avoid papules and nodules with PLLA (Sculptra) include:

▸ Adjust dilution volume to fit the clinical situation. Small dilution volumes can lead to nonhomogeneous distribution—and increased likelihood of nodules.

"The product insert says use 3-5 mL because that's how the original studies were done. But I've learned with this product that to have a more robust response, as in an on-label patient [with HIV-related facial lipoatrophy], I'll increase the total diluent to 6 mL per vial," he said.

▸ Use the appropriate gauge needle. Dr. Mest's analysis of the published literature suggests that adverse event rates are similar with 25- and 26-gauge needles. Using a smaller-gauge needle than 25 is not recommended, he said.

▸ Supraperiosteal placement is best. "This way you're only going to have volume go outward, so if you have any problems you're not going to feel them. Personally in the midface I'll do a supraperiosteal placement, then a more superficial placement, staying out of any active muscle areas," he explained.

▸ Don't overcorrect. PLLA is a pure biostimulant. The improvement may not be evident for 4-6 weeks or longer.

▸ Don't superficially place. "You should not see your needle when you're doing this. It's not a dermal product," he noted.

▸ Treat nodules conservatively. In a clinical trial led by Dr. Mest, 12 of 13 nodules that occurred resolved spontaneously during 36 months of follow-up. "I don't recommend aggressively treating the nodules and papules with high-dose steroids," said Dr. Mest, who serves as a consultant to Dermik Laboratories, which markets Sculptra.

SDEF and this news organization are owned by Elsevier.

MAUI, HAWAII — A key to minimizing the risk of bump and nodule formation when injecting poly-L-lactic acid is uniform product distribution by lengthening the dilution time, according to Dr. Douglas Mest.

"I will not inject PLLA if it hasn't been hydrated at least overnight. Longer is even better. The product insert allows for up to 72 hours hydration in sterile water; if you use bacteriostatic sterile water I think it's fine to keep it longer. Most experts keep it around for up to 3 weeks," Dr. Mest said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

The hydrated product can be kept in the refrigerator but should be brought to room temperature before injection. It should not be heated because that can damage the microscopic PLLA particles, according to Dr. Mest of the Blue Pacific Aesthetic Medical Group, El Segundo, Calif.

Other tips he offered to avoid papules and nodules with PLLA (Sculptra) include:

▸ Adjust dilution volume to fit the clinical situation. Small dilution volumes can lead to nonhomogeneous distribution—and increased likelihood of nodules.

"The product insert says use 3-5 mL because that's how the original studies were done. But I've learned with this product that to have a more robust response, as in an on-label patient [with HIV-related facial lipoatrophy], I'll increase the total diluent to 6 mL per vial," he said.

▸ Use the appropriate gauge needle. Dr. Mest's analysis of the published literature suggests that adverse event rates are similar with 25- and 26-gauge needles. Using a smaller-gauge needle than 25 is not recommended, he said.

▸ Supraperiosteal placement is best. "This way you're only going to have volume go outward, so if you have any problems you're not going to feel them. Personally in the midface I'll do a supraperiosteal placement, then a more superficial placement, staying out of any active muscle areas," he explained.

▸ Don't overcorrect. PLLA is a pure biostimulant. The improvement may not be evident for 4-6 weeks or longer.

▸ Don't superficially place. "You should not see your needle when you're doing this. It's not a dermal product," he noted.

▸ Treat nodules conservatively. In a clinical trial led by Dr. Mest, 12 of 13 nodules that occurred resolved spontaneously during 36 months of follow-up. "I don't recommend aggressively treating the nodules and papules with high-dose steroids," said Dr. Mest, who serves as a consultant to Dermik Laboratories, which markets Sculptra.

SDEF and this news organization are owned by Elsevier.

MAUI, HAWAII — A key to minimizing the risk of bump and nodule formation when injecting poly-L-lactic acid is uniform product distribution by lengthening the dilution time, according to Dr. Douglas Mest.

"I will not inject PLLA if it hasn't been hydrated at least overnight. Longer is even better. The product insert allows for up to 72 hours hydration in sterile water; if you use bacteriostatic sterile water I think it's fine to keep it longer. Most experts keep it around for up to 3 weeks," Dr. Mest said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

The hydrated product can be kept in the refrigerator but should be brought to room temperature before injection. It should not be heated because that can damage the microscopic PLLA particles, according to Dr. Mest of the Blue Pacific Aesthetic Medical Group, El Segundo, Calif.

Other tips he offered to avoid papules and nodules with PLLA (Sculptra) include:

▸ Adjust dilution volume to fit the clinical situation. Small dilution volumes can lead to nonhomogeneous distribution—and increased likelihood of nodules.

"The product insert says use 3-5 mL because that's how the original studies were done. But I've learned with this product that to have a more robust response, as in an on-label patient [with HIV-related facial lipoatrophy], I'll increase the total diluent to 6 mL per vial," he said.

▸ Use the appropriate gauge needle. Dr. Mest's analysis of the published literature suggests that adverse event rates are similar with 25- and 26-gauge needles. Using a smaller-gauge needle than 25 is not recommended, he said.

▸ Supraperiosteal placement is best. "This way you're only going to have volume go outward, so if you have any problems you're not going to feel them. Personally in the midface I'll do a supraperiosteal placement, then a more superficial placement, staying out of any active muscle areas," he explained.

▸ Don't overcorrect. PLLA is a pure biostimulant. The improvement may not be evident for 4-6 weeks or longer.

▸ Don't superficially place. "You should not see your needle when you're doing this. It's not a dermal product," he noted.

▸ Treat nodules conservatively. In a clinical trial led by Dr. Mest, 12 of 13 nodules that occurred resolved spontaneously during 36 months of follow-up. "I don't recommend aggressively treating the nodules and papules with high-dose steroids," said Dr. Mest, who serves as a consultant to Dermik Laboratories, which markets Sculptra.

SDEF and this news organization are owned by Elsevier.

Although a variety of injectable cosmetic fillers are in high demand, physicians should be aware that rare adverse reactions—like foreign body granulomas—are being reported, according to a case report.

Injectable permanent fillers containing polymethyl methacrylate (PMMA) immersed in a solution of collagen have been implicated in several types of adverse reactions, reported Dr. M.C. da Costa Miguel of the department of oral pathology at the Federal University of Rio Grande do Norte, Brazil, and his colleagues.

Foreign body granulomas only develop in some patients, and this particular granuloma formation caused by a reaction to injectable fillers is only observed in 0.01% of patients, further adding to the diagnostic challenge, the researchers wrote.

Dr. da Costa and his colleagues found the granulomas in a 56-year-old woman after performing a number of examinations. Initial examinations showed a "firm, pink nodule covered with non-ulcerated mucosa located in the right anterior inferior alveolar mucosa." The swelling was painless and moveable. There was no bone involvement, no palpable adenopathies, and the patient showed no symptoms of atopy (Int. J. Oral Maxillofac. Surg. 2009;38:385-7).

Salivary gland mucocoele was considered initiallly. After a biopsy, the researchers found that "immunohistochemical analysis using anti-CD68 antibody confirmed the presence of numerous macrophages and CD68-positive multinucleated giant cells."

The patient was asked if any aesthetic procedure had been performed close to the site of her swelling and she confirmed that she had an injection of a cosmetic filler containing PMMA for lip enlargement about 1 year earlier.

According to Dr. da Costa and his colleagues, what made this case particularly rare was its "unusual clinical presentation as a painless nodule located exclusively inside the oral cavity." They described the lesion as "indistinguishable from other pathologies such as salivary gland mucocoele or soft tissue neoplasm."

Foreign body granulomas can be successfully treated with intralesional or systemic corticosteroids, they noted. In this case, simple surgical excision was performed because it was a well-demarcated lesion.

Dr. da Costa and colleagues reported having no conflicts of interest.

Although a variety of injectable cosmetic fillers are in high demand, physicians should be aware that rare adverse reactions—like foreign body granulomas—are being reported, according to a case report.

Injectable permanent fillers containing polymethyl methacrylate (PMMA) immersed in a solution of collagen have been implicated in several types of adverse reactions, reported Dr. M.C. da Costa Miguel of the department of oral pathology at the Federal University of Rio Grande do Norte, Brazil, and his colleagues.

Foreign body granulomas only develop in some patients, and this particular granuloma formation caused by a reaction to injectable fillers is only observed in 0.01% of patients, further adding to the diagnostic challenge, the researchers wrote.

Dr. da Costa and his colleagues found the granulomas in a 56-year-old woman after performing a number of examinations. Initial examinations showed a "firm, pink nodule covered with non-ulcerated mucosa located in the right anterior inferior alveolar mucosa." The swelling was painless and moveable. There was no bone involvement, no palpable adenopathies, and the patient showed no symptoms of atopy (Int. J. Oral Maxillofac. Surg. 2009;38:385-7).

Salivary gland mucocoele was considered initiallly. After a biopsy, the researchers found that "immunohistochemical analysis using anti-CD68 antibody confirmed the presence of numerous macrophages and CD68-positive multinucleated giant cells."

The patient was asked if any aesthetic procedure had been performed close to the site of her swelling and she confirmed that she had an injection of a cosmetic filler containing PMMA for lip enlargement about 1 year earlier.

According to Dr. da Costa and his colleagues, what made this case particularly rare was its "unusual clinical presentation as a painless nodule located exclusively inside the oral cavity." They described the lesion as "indistinguishable from other pathologies such as salivary gland mucocoele or soft tissue neoplasm."

Foreign body granulomas can be successfully treated with intralesional or systemic corticosteroids, they noted. In this case, simple surgical excision was performed because it was a well-demarcated lesion.

Dr. da Costa and colleagues reported having no conflicts of interest.

Although a variety of injectable cosmetic fillers are in high demand, physicians should be aware that rare adverse reactions—like foreign body granulomas—are being reported, according to a case report.

Injectable permanent fillers containing polymethyl methacrylate (PMMA) immersed in a solution of collagen have been implicated in several types of adverse reactions, reported Dr. M.C. da Costa Miguel of the department of oral pathology at the Federal University of Rio Grande do Norte, Brazil, and his colleagues.

Foreign body granulomas only develop in some patients, and this particular granuloma formation caused by a reaction to injectable fillers is only observed in 0.01% of patients, further adding to the diagnostic challenge, the researchers wrote.

Dr. da Costa and his colleagues found the granulomas in a 56-year-old woman after performing a number of examinations. Initial examinations showed a "firm, pink nodule covered with non-ulcerated mucosa located in the right anterior inferior alveolar mucosa." The swelling was painless and moveable. There was no bone involvement, no palpable adenopathies, and the patient showed no symptoms of atopy (Int. J. Oral Maxillofac. Surg. 2009;38:385-7).

Salivary gland mucocoele was considered initiallly. After a biopsy, the researchers found that "immunohistochemical analysis using anti-CD68 antibody confirmed the presence of numerous macrophages and CD68-positive multinucleated giant cells."

The patient was asked if any aesthetic procedure had been performed close to the site of her swelling and she confirmed that she had an injection of a cosmetic filler containing PMMA for lip enlargement about 1 year earlier.

According to Dr. da Costa and his colleagues, what made this case particularly rare was its "unusual clinical presentation as a painless nodule located exclusively inside the oral cavity." They described the lesion as "indistinguishable from other pathologies such as salivary gland mucocoele or soft tissue neoplasm."

Foreign body granulomas can be successfully treated with intralesional or systemic corticosteroids, they noted. In this case, simple surgical excision was performed because it was a well-demarcated lesion.

Dr. da Costa and colleagues reported having no conflicts of interest.

MAUI, HAWAII — Snapping a set of before and after photos at an unconventional 22.5-degree angle in addition to the standard anteroposterior, lateral, and oblique shots often makes it easier for patients to recognize the improvement they have gained with poly-L-lactic acid injections, according to one expert.

"The mechanism of action with PLLA [Sculptra] is so delayed that patients forget what they looked like. A set of photos taken at a less acute 22.5-degree angle shows the convexity of the malar eminence better. You notice the baseline volume loss much more," Dr. Douglas R. Mest explained at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

Facial volume loss averages 1 teaspoon per year after age 40. It's due to a combination of facial fat loss and redistribution, bone resorption, facial muscle atrophy, and dermal thinning. This volume deficit is a three-dimensional cosmetic problem, and PLLA—a pure biostimulant—is the best treatment for it yet, according to Dr. Mest, an anesthesiologist specializing in cosmetic dermatology in Manhattan Beach, Calif., and the chief investigator in the phase III trial that won approval of PLLA for the treatment of HIV-related facial lipoatrophy.

In addition to recommending shooting those 22.5-degree before and after photos, Dr. Mest shared other tips in getting the most out of PLLA:

▸ Start with the standard treatment areas. PLLA is quite unlike other facial fillers, and there is a definite learning curve in its use. The cheeks are the easiest area in which to achieve volume replacement. Other standard areas are the nasolabial folds, submental area and jawline, and marionette lines.

"What we've learned about staying out of trouble is that there are areas that are very easy to treat with biostimulating products, including calcium hydroxyapatite [Radiesse] and PLLA, and if you're starting out, that's where to start," he said.

Advanced treatment areas are those where treatment-induced lumps or bumps are more apt to show, either due to thin skin or because active muscle groups sweep up the product and make it more visible. The upper lip, temples, hands, and neck fall into this category.

▸ Delay treatment. The product labeling says to wait at least 4 weeks between PLLA treatments. Dr. Mest said he now routinely waits at least 6 weeks. That's because collagen synthesis doesn't really get underway until 2-3 weeks after treatment.

"Sometimes when you treat at 4 weeks, patients will not necessarily have seen the improvement. I think if you wait another 2 weeks you'll see it," he explained.

Some experienced physicians now wait 3 months between PLLA treatments, but "I find 6 weeks is a nice compromise," Dr. Mest added.

▸ Treat the whole face, not individual lines. "Patients often come in asking for treatment of certain lines or wrinkles, when what they really need is treatment of the underlying region with a deep revolumizing agent. The example I use with patients is instead of treating each line on the raisin to make it a grape, we add volume back to the raisin to make it a grape," he said.

▸ Tackle the temple hollows. This reproportions the face, restoring the triangle of youth and making for a less severe look, but is best taken on after gaining skill with PLLA.

"Patients seldom come in asking for treatment of temple hollowing, but once you see it done you start noticing how many people need it," according to Dr. Mest.

He disclosed that he is a consultant to Dermik Laboratories Inc. and a physician trainer for BioForm Medical Inc.

SDEF and this news organization are owned by Elsevier.

The pretreatment photo at left was taken at a 45-degee angle. In the photo at right, taken at a 22.5-degree angle, the area needing treatment is more obvious. Photos courtesy Dr. Douglas Mest

MAUI, HAWAII — Snapping a set of before and after photos at an unconventional 22.5-degree angle in addition to the standard anteroposterior, lateral, and oblique shots often makes it easier for patients to recognize the improvement they have gained with poly-L-lactic acid injections, according to one expert.

"The mechanism of action with PLLA [Sculptra] is so delayed that patients forget what they looked like. A set of photos taken at a less acute 22.5-degree angle shows the convexity of the malar eminence better. You notice the baseline volume loss much more," Dr. Douglas R. Mest explained at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

Facial volume loss averages 1 teaspoon per year after age 40. It's due to a combination of facial fat loss and redistribution, bone resorption, facial muscle atrophy, and dermal thinning. This volume deficit is a three-dimensional cosmetic problem, and PLLA—a pure biostimulant—is the best treatment for it yet, according to Dr. Mest, an anesthesiologist specializing in cosmetic dermatology in Manhattan Beach, Calif., and the chief investigator in the phase III trial that won approval of PLLA for the treatment of HIV-related facial lipoatrophy.

In addition to recommending shooting those 22.5-degree before and after photos, Dr. Mest shared other tips in getting the most out of PLLA:

▸ Start with the standard treatment areas. PLLA is quite unlike other facial fillers, and there is a definite learning curve in its use. The cheeks are the easiest area in which to achieve volume replacement. Other standard areas are the nasolabial folds, submental area and jawline, and marionette lines.

"What we've learned about staying out of trouble is that there are areas that are very easy to treat with biostimulating products, including calcium hydroxyapatite [Radiesse] and PLLA, and if you're starting out, that's where to start," he said.

Advanced treatment areas are those where treatment-induced lumps or bumps are more apt to show, either due to thin skin or because active muscle groups sweep up the product and make it more visible. The upper lip, temples, hands, and neck fall into this category.

▸ Delay treatment. The product labeling says to wait at least 4 weeks between PLLA treatments. Dr. Mest said he now routinely waits at least 6 weeks. That's because collagen synthesis doesn't really get underway until 2-3 weeks after treatment.

"Sometimes when you treat at 4 weeks, patients will not necessarily have seen the improvement. I think if you wait another 2 weeks you'll see it," he explained.

Some experienced physicians now wait 3 months between PLLA treatments, but "I find 6 weeks is a nice compromise," Dr. Mest added.

▸ Treat the whole face, not individual lines. "Patients often come in asking for treatment of certain lines or wrinkles, when what they really need is treatment of the underlying region with a deep revolumizing agent. The example I use with patients is instead of treating each line on the raisin to make it a grape, we add volume back to the raisin to make it a grape," he said.

▸ Tackle the temple hollows. This reproportions the face, restoring the triangle of youth and making for a less severe look, but is best taken on after gaining skill with PLLA.

"Patients seldom come in asking for treatment of temple hollowing, but once you see it done you start noticing how many people need it," according to Dr. Mest.

He disclosed that he is a consultant to Dermik Laboratories Inc. and a physician trainer for BioForm Medical Inc.

SDEF and this news organization are owned by Elsevier.

The pretreatment photo at left was taken at a 45-degee angle. In the photo at right, taken at a 22.5-degree angle, the area needing treatment is more obvious. Photos courtesy Dr. Douglas Mest

MAUI, HAWAII — Snapping a set of before and after photos at an unconventional 22.5-degree angle in addition to the standard anteroposterior, lateral, and oblique shots often makes it easier for patients to recognize the improvement they have gained with poly-L-lactic acid injections, according to one expert.

"The mechanism of action with PLLA [Sculptra] is so delayed that patients forget what they looked like. A set of photos taken at a less acute 22.5-degree angle shows the convexity of the malar eminence better. You notice the baseline volume loss much more," Dr. Douglas R. Mest explained at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

Facial volume loss averages 1 teaspoon per year after age 40. It's due to a combination of facial fat loss and redistribution, bone resorption, facial muscle atrophy, and dermal thinning. This volume deficit is a three-dimensional cosmetic problem, and PLLA—a pure biostimulant—is the best treatment for it yet, according to Dr. Mest, an anesthesiologist specializing in cosmetic dermatology in Manhattan Beach, Calif., and the chief investigator in the phase III trial that won approval of PLLA for the treatment of HIV-related facial lipoatrophy.

In addition to recommending shooting those 22.5-degree before and after photos, Dr. Mest shared other tips in getting the most out of PLLA:

▸ Start with the standard treatment areas. PLLA is quite unlike other facial fillers, and there is a definite learning curve in its use. The cheeks are the easiest area in which to achieve volume replacement. Other standard areas are the nasolabial folds, submental area and jawline, and marionette lines.

"What we've learned about staying out of trouble is that there are areas that are very easy to treat with biostimulating products, including calcium hydroxyapatite [Radiesse] and PLLA, and if you're starting out, that's where to start," he said.

Advanced treatment areas are those where treatment-induced lumps or bumps are more apt to show, either due to thin skin or because active muscle groups sweep up the product and make it more visible. The upper lip, temples, hands, and neck fall into this category.

▸ Delay treatment. The product labeling says to wait at least 4 weeks between PLLA treatments. Dr. Mest said he now routinely waits at least 6 weeks. That's because collagen synthesis doesn't really get underway until 2-3 weeks after treatment.

"Sometimes when you treat at 4 weeks, patients will not necessarily have seen the improvement. I think if you wait another 2 weeks you'll see it," he explained.

Some experienced physicians now wait 3 months between PLLA treatments, but "I find 6 weeks is a nice compromise," Dr. Mest added.

▸ Treat the whole face, not individual lines. "Patients often come in asking for treatment of certain lines or wrinkles, when what they really need is treatment of the underlying region with a deep revolumizing agent. The example I use with patients is instead of treating each line on the raisin to make it a grape, we add volume back to the raisin to make it a grape," he said.

▸ Tackle the temple hollows. This reproportions the face, restoring the triangle of youth and making for a less severe look, but is best taken on after gaining skill with PLLA.

"Patients seldom come in asking for treatment of temple hollowing, but once you see it done you start noticing how many people need it," according to Dr. Mest.

He disclosed that he is a consultant to Dermik Laboratories Inc. and a physician trainer for BioForm Medical Inc.

SDEF and this news organization are owned by Elsevier.

The pretreatment photo at left was taken at a 45-degee angle. In the photo at right, taken at a 22.5-degree angle, the area needing treatment is more obvious. Photos courtesy Dr. Douglas Mest

SAN FRANCISCO — A cream containing an onion extract and UVA and UVB sun protection significantly improves the appearance and feel of postsurgical scars, a small randomized trial found.

Nonprescription Mederma cream plus SPF 30 performed in the study comparably to Mederma onion extract gel without SPF for reduction of postsurgical scarring. Additionally, patients rated the cream as significantly more soothing than Mederma gel, Dr. Zoe D. Draelos reported at the annual meeting of the American Academy of Dermatology.

No placebo arm was included in the comparative trial because the study aim was to establish whether parity exists between the two onion extract formulations, both marketed OTC by Merz Pharmaceuticals, which sponsored the study. The gel formulation, which doesn't include sun protection, had already demonstrated superiority to placebo in an earlier randomized trial conducted by Dr. Draelos (J. Cosmet. Dermatol. 2008;7:101-4).

The new trial involved 20 patients with symmetric seborrheic keratoses at least 8 mm in diameter located on their right and left upper chest. The lesions were removed with a scalpel shave under local anesthesia. After the wound sites were permitted to heal for 2 weeks, patients returned for randomization. Three times daily for 8 weeks, they put a thin layer of the onion extract cream on the right chest scar and a layer of gel on the left chest scar, or vice versa, explained Dr. Draelos, who practices in High Point, N.C.

Blinded investigator assessment of the scars documented by photography showed significant improvement over time on 4-point scales assessing scar redness, texture, softness, and global appearance. The degree of improvement was similar for onion extract cream- and gel-treated scars.

There was also significantly less transepidermal water loss at the onion extract cream-treated excision sites than the gel-treated sites after treatment, probably because of the moisturizing base in the cream vehicle.

The therapeutic basis for the onion extract product's efficacy is believed to lie in its anti-inflammatory effects and its inhibition of fibroblast proliferation. The SPF 30 sun protection was incorporated into the cream formulation because scars are sunlight sensitive, and once they sunburn they often darken and become cosmetically unacceptable, she explained.

Dr. Draelos disclosed that she is a consultant to Merz and has been paid to conduct research for numerous pharmaceutical companies.

SAN FRANCISCO — A cream containing an onion extract and UVA and UVB sun protection significantly improves the appearance and feel of postsurgical scars, a small randomized trial found.

Nonprescription Mederma cream plus SPF 30 performed in the study comparably to Mederma onion extract gel without SPF for reduction of postsurgical scarring. Additionally, patients rated the cream as significantly more soothing than Mederma gel, Dr. Zoe D. Draelos reported at the annual meeting of the American Academy of Dermatology.

No placebo arm was included in the comparative trial because the study aim was to establish whether parity exists between the two onion extract formulations, both marketed OTC by Merz Pharmaceuticals, which sponsored the study. The gel formulation, which doesn't include sun protection, had already demonstrated superiority to placebo in an earlier randomized trial conducted by Dr. Draelos (J. Cosmet. Dermatol. 2008;7:101-4).

The new trial involved 20 patients with symmetric seborrheic keratoses at least 8 mm in diameter located on their right and left upper chest. The lesions were removed with a scalpel shave under local anesthesia. After the wound sites were permitted to heal for 2 weeks, patients returned for randomization. Three times daily for 8 weeks, they put a thin layer of the onion extract cream on the right chest scar and a layer of gel on the left chest scar, or vice versa, explained Dr. Draelos, who practices in High Point, N.C.

Blinded investigator assessment of the scars documented by photography showed significant improvement over time on 4-point scales assessing scar redness, texture, softness, and global appearance. The degree of improvement was similar for onion extract cream- and gel-treated scars.

There was also significantly less transepidermal water loss at the onion extract cream-treated excision sites than the gel-treated sites after treatment, probably because of the moisturizing base in the cream vehicle.

The therapeutic basis for the onion extract product's efficacy is believed to lie in its anti-inflammatory effects and its inhibition of fibroblast proliferation. The SPF 30 sun protection was incorporated into the cream formulation because scars are sunlight sensitive, and once they sunburn they often darken and become cosmetically unacceptable, she explained.

Dr. Draelos disclosed that she is a consultant to Merz and has been paid to conduct research for numerous pharmaceutical companies.

SAN FRANCISCO — A cream containing an onion extract and UVA and UVB sun protection significantly improves the appearance and feel of postsurgical scars, a small randomized trial found.

Nonprescription Mederma cream plus SPF 30 performed in the study comparably to Mederma onion extract gel without SPF for reduction of postsurgical scarring. Additionally, patients rated the cream as significantly more soothing than Mederma gel, Dr. Zoe D. Draelos reported at the annual meeting of the American Academy of Dermatology.

No placebo arm was included in the comparative trial because the study aim was to establish whether parity exists between the two onion extract formulations, both marketed OTC by Merz Pharmaceuticals, which sponsored the study. The gel formulation, which doesn't include sun protection, had already demonstrated superiority to placebo in an earlier randomized trial conducted by Dr. Draelos (J. Cosmet. Dermatol. 2008;7:101-4).

The new trial involved 20 patients with symmetric seborrheic keratoses at least 8 mm in diameter located on their right and left upper chest. The lesions were removed with a scalpel shave under local anesthesia. After the wound sites were permitted to heal for 2 weeks, patients returned for randomization. Three times daily for 8 weeks, they put a thin layer of the onion extract cream on the right chest scar and a layer of gel on the left chest scar, or vice versa, explained Dr. Draelos, who practices in High Point, N.C.

Blinded investigator assessment of the scars documented by photography showed significant improvement over time on 4-point scales assessing scar redness, texture, softness, and global appearance. The degree of improvement was similar for onion extract cream- and gel-treated scars.

There was also significantly less transepidermal water loss at the onion extract cream-treated excision sites than the gel-treated sites after treatment, probably because of the moisturizing base in the cream vehicle.

The therapeutic basis for the onion extract product's efficacy is believed to lie in its anti-inflammatory effects and its inhibition of fibroblast proliferation. The SPF 30 sun protection was incorporated into the cream formulation because scars are sunlight sensitive, and once they sunburn they often darken and become cosmetically unacceptable, she explained.

Dr. Draelos disclosed that she is a consultant to Merz and has been paid to conduct research for numerous pharmaceutical companies.