Aesthetic Dermatology

MIAMI BEACH – Calls for a ban on the use of tanning beds by minors in the United States have thus far gone unheeded, but medical organizations are increasingly supporting such a ban – and with good reason, according to Alan Geller of the Harvard School of Public Health, Boston.

The data linking tanning bed use and melanoma are consistent and convincing. A 2010 University of Minnesota case-control study, for example, demonstrated that melanoma risk was significantly increased among users, compared with nonusers, of UVB-enhanced tanning devices (adjusted odds ratio, 2.86) and primarily UVA-emitting devices (AOR, 4.44), Mr. Geller said at the annual meeting of the American Academy of Dermatology.

©Vidmantas Goldbergas/iStockphoto.com

The risk increased as tanning bed use increased (Cancer Epidemiol. Biomarkers Prev. 2010;19:1557-68).

A more recent study demonstrated that with every visit to a tanning bed, the risk of melanoma increased by 1.8% – and the risk was even greater among those who started tanning at a younger age (BMJ 2012;345:e4757).

"We are clearly in the throes of a modern-day epidemic, particularly among teenage white girls and young women between the ages of 18 and 25," Mr. Geller said, noting that study after study shows that about a third of white teenage girls and about 20% of all teenage girls use a tanning bed by the age of 17.

And yet only five states restrict the use of tanning beds by those under age 18. Others have parental consent restrictions, but these have been shown to have no effect on tanning bed use by minors. That means that in 45 states, children aged 15 years and younger are free to visit tanning salons with no restrictions, he said, noting that a Washington University in St. Louis survey released in February showed that 65% of Missouri tanning salon owners would allow preteens aged 10-12 years to use their tanning beds – and that 43% of tanning salon employees believe indoor tanning poses no health risks.

Data show that 7% of girls use tanning beds by age 14 years. This doubles from age 14 to 15, and doubles again from age 15 to 17, he said, noting that girls are about five to six times more likely than boys to use tanning beds.

Of particular concern, not only are girls using tanning beds early, but they are using them more often.

A Centers for Disease Control and Prevention survey showed that while the rate of use (20% among all girls) has remained constant in recent years, the "prom phenomenon" – the occasional use of tanning beds before a special event – is no longer the norm; the average yearly number of uses of tanning beds among those surveyed was 28.

"We’re way past the prom phenomenon," Mr. Geller said, noting that one reason for this is that tanning salons "do a wonderful job of selling giant packages of use for very little money."

"When people are beginning to think of some kind of restrictions on the tanning bed industry, that would be one we could surely consider," he said, noting that based on the data showing a 1.8% increase in melanoma risk with each tanning bed use, the risk would be 54%-90% in a teen who starts tanning at age 18 and quits at age 19.

That’s a conservative estimate, because most teens start before age 18 and don’t stop at age 19, he said.

Surveillance, Epidemiology, and End Results (SEER) data from the National Cancer Institute show that the risk of melanoma has doubled among women aged 20-24 years since the 1980s, while the risk in men has declined in some age groups, and remained the same in others.

"You have to ask what’s happened during that time," Mr. Geller said, adding that there is concern about the late effects of tanning bed use, especially given that sun exposure time hasn’t changed in that age group over time.

As for what can be done from a public health perspective to reduce tanning bed use, Mr. Geller said a number of research, legislative, and public health campaigns are underway.

"We know from doing qualitative work, that indoor tanning is largely socially driven. "When [girls] are not tanning, they talk about tanning, they blog about tanning," he said, explaining that "the tanning culture involves some kind of socially driven bonds."

The key is to figure out how to break up those bonds.

"If one girl in a social group quits tanning, will this have an effect on the others? We don’t know," he said, adding that this is among the areas that require further research.

Researchers are also studying the effects of antitanning campaigns and legislation in other countries, a number of which have restricted access to tanning beds for minors. A recent web-based advertising campaign in Denmark targeted teens, and, along with legislation restricting access, resulted in a substantial drop in tanning bed use there, he said.

The results of campaigns and legislative efforts like these are being closely monitored so that the lessons learned about if and how they work can be incorporated into efforts here.

Lessons from the campaign against smoking launched three decades ago also are being incorporated into the current effort to reduce tanning, he said.

Although the link between tanning and melanoma isn’t quite as strong as the link between smoking and lung cancer, the seven key principles that made the antismoking campaign a success can be adapted for this purpose. These are surveillance, taxation, legal strategies, public health advertising campaigns, educational programs, legislation, and "some move to mandate enforcement," he said.

Some progress has been made with respect to these principles. For example, state-by-state surveillance and scoring of states’ level of compliance with existing regulations are underway, a 10% tax has been imposed on tanning salons, cost-efficacy studies are being planned, and lawsuits have been filed in multiple states. However, most of these efforts are in their infancy, Mr. Geller said.

For now, what exists across the United States is a "patchwork quilt of pretty crummy regulations," he said.

While intense pressure is on the Food and Drug Administration to ban tanning bed use by those under age 18 – including pressure from the American Academy of Dermatology – and while the agency is cognizant of the risks and has acknowledged a need for more regulations, "politics have prevailed, and at this point we don’t have the ban," he said.

The FDA website does, however, indicate plans for revising regulations and strengthening warning labels to make consumers more aware of the risks, he noted.

"This is good, but I think it’s a really faulty response to everything that we know about the link between tanning beds and melanoma," he said.

Despite the slow progress toward a ban for those under age 18, there have been some successes in the antitanning campaign. For one, numerous organizations have taken up the cause, including the World Health Organization, the American Academy of Pediatrics, the American Medical Association, the Society of Surgical Oncology, and the Canadian Pediatric Society.

Also, thanks to a Federal Trade Commission crackdown in 2010, the tanning industry is no longer allowed to claim that tanning has certain health benefits, such as reducing the risks of some types of cancers. And in 2012, the U.S. Preventive Services Task Force issued its first guidelines on tanning, stating that the evidence is strong enough to recommend that women aged 10-24 years who have fair skin should avoid prime-time sun exposure and tanning beds.

Additionally, a wellness provision of the Patient Protection and Affordable Care Act that will go into effect in May provides for full reimbursement to health care providers for counseling about skin cancer prevention and tanning bed reduction.

"We want to study this because we think this will have a huge effect on increasing the rate of counseling," he said.

Mr. Geller reported having no disclosures.

MIAMI BEACH – Calls for a ban on the use of tanning beds by minors in the United States have thus far gone unheeded, but medical organizations are increasingly supporting such a ban – and with good reason, according to Alan Geller of the Harvard School of Public Health, Boston.

The data linking tanning bed use and melanoma are consistent and convincing. A 2010 University of Minnesota case-control study, for example, demonstrated that melanoma risk was significantly increased among users, compared with nonusers, of UVB-enhanced tanning devices (adjusted odds ratio, 2.86) and primarily UVA-emitting devices (AOR, 4.44), Mr. Geller said at the annual meeting of the American Academy of Dermatology.

©Vidmantas Goldbergas/iStockphoto.com

The risk increased as tanning bed use increased (Cancer Epidemiol. Biomarkers Prev. 2010;19:1557-68).

A more recent study demonstrated that with every visit to a tanning bed, the risk of melanoma increased by 1.8% – and the risk was even greater among those who started tanning at a younger age (BMJ 2012;345:e4757).

"We are clearly in the throes of a modern-day epidemic, particularly among teenage white girls and young women between the ages of 18 and 25," Mr. Geller said, noting that study after study shows that about a third of white teenage girls and about 20% of all teenage girls use a tanning bed by the age of 17.

And yet only five states restrict the use of tanning beds by those under age 18. Others have parental consent restrictions, but these have been shown to have no effect on tanning bed use by minors. That means that in 45 states, children aged 15 years and younger are free to visit tanning salons with no restrictions, he said, noting that a Washington University in St. Louis survey released in February showed that 65% of Missouri tanning salon owners would allow preteens aged 10-12 years to use their tanning beds – and that 43% of tanning salon employees believe indoor tanning poses no health risks.

Data show that 7% of girls use tanning beds by age 14 years. This doubles from age 14 to 15, and doubles again from age 15 to 17, he said, noting that girls are about five to six times more likely than boys to use tanning beds.

Of particular concern, not only are girls using tanning beds early, but they are using them more often.

A Centers for Disease Control and Prevention survey showed that while the rate of use (20% among all girls) has remained constant in recent years, the "prom phenomenon" – the occasional use of tanning beds before a special event – is no longer the norm; the average yearly number of uses of tanning beds among those surveyed was 28.

"We’re way past the prom phenomenon," Mr. Geller said, noting that one reason for this is that tanning salons "do a wonderful job of selling giant packages of use for very little money."

"When people are beginning to think of some kind of restrictions on the tanning bed industry, that would be one we could surely consider," he said, noting that based on the data showing a 1.8% increase in melanoma risk with each tanning bed use, the risk would be 54%-90% in a teen who starts tanning at age 18 and quits at age 19.

That’s a conservative estimate, because most teens start before age 18 and don’t stop at age 19, he said.

Surveillance, Epidemiology, and End Results (SEER) data from the National Cancer Institute show that the risk of melanoma has doubled among women aged 20-24 years since the 1980s, while the risk in men has declined in some age groups, and remained the same in others.

"You have to ask what’s happened during that time," Mr. Geller said, adding that there is concern about the late effects of tanning bed use, especially given that sun exposure time hasn’t changed in that age group over time.

As for what can be done from a public health perspective to reduce tanning bed use, Mr. Geller said a number of research, legislative, and public health campaigns are underway.

"We know from doing qualitative work, that indoor tanning is largely socially driven. "When [girls] are not tanning, they talk about tanning, they blog about tanning," he said, explaining that "the tanning culture involves some kind of socially driven bonds."

The key is to figure out how to break up those bonds.

"If one girl in a social group quits tanning, will this have an effect on the others? We don’t know," he said, adding that this is among the areas that require further research.

Researchers are also studying the effects of antitanning campaigns and legislation in other countries, a number of which have restricted access to tanning beds for minors. A recent web-based advertising campaign in Denmark targeted teens, and, along with legislation restricting access, resulted in a substantial drop in tanning bed use there, he said.

The results of campaigns and legislative efforts like these are being closely monitored so that the lessons learned about if and how they work can be incorporated into efforts here.

Lessons from the campaign against smoking launched three decades ago also are being incorporated into the current effort to reduce tanning, he said.

Although the link between tanning and melanoma isn’t quite as strong as the link between smoking and lung cancer, the seven key principles that made the antismoking campaign a success can be adapted for this purpose. These are surveillance, taxation, legal strategies, public health advertising campaigns, educational programs, legislation, and "some move to mandate enforcement," he said.

Some progress has been made with respect to these principles. For example, state-by-state surveillance and scoring of states’ level of compliance with existing regulations are underway, a 10% tax has been imposed on tanning salons, cost-efficacy studies are being planned, and lawsuits have been filed in multiple states. However, most of these efforts are in their infancy, Mr. Geller said.

For now, what exists across the United States is a "patchwork quilt of pretty crummy regulations," he said.

While intense pressure is on the Food and Drug Administration to ban tanning bed use by those under age 18 – including pressure from the American Academy of Dermatology – and while the agency is cognizant of the risks and has acknowledged a need for more regulations, "politics have prevailed, and at this point we don’t have the ban," he said.

The FDA website does, however, indicate plans for revising regulations and strengthening warning labels to make consumers more aware of the risks, he noted.

"This is good, but I think it’s a really faulty response to everything that we know about the link between tanning beds and melanoma," he said.

Despite the slow progress toward a ban for those under age 18, there have been some successes in the antitanning campaign. For one, numerous organizations have taken up the cause, including the World Health Organization, the American Academy of Pediatrics, the American Medical Association, the Society of Surgical Oncology, and the Canadian Pediatric Society.

Also, thanks to a Federal Trade Commission crackdown in 2010, the tanning industry is no longer allowed to claim that tanning has certain health benefits, such as reducing the risks of some types of cancers. And in 2012, the U.S. Preventive Services Task Force issued its first guidelines on tanning, stating that the evidence is strong enough to recommend that women aged 10-24 years who have fair skin should avoid prime-time sun exposure and tanning beds.

Additionally, a wellness provision of the Patient Protection and Affordable Care Act that will go into effect in May provides for full reimbursement to health care providers for counseling about skin cancer prevention and tanning bed reduction.

"We want to study this because we think this will have a huge effect on increasing the rate of counseling," he said.

Mr. Geller reported having no disclosures.

MIAMI BEACH – Calls for a ban on the use of tanning beds by minors in the United States have thus far gone unheeded, but medical organizations are increasingly supporting such a ban – and with good reason, according to Alan Geller of the Harvard School of Public Health, Boston.

The data linking tanning bed use and melanoma are consistent and convincing. A 2010 University of Minnesota case-control study, for example, demonstrated that melanoma risk was significantly increased among users, compared with nonusers, of UVB-enhanced tanning devices (adjusted odds ratio, 2.86) and primarily UVA-emitting devices (AOR, 4.44), Mr. Geller said at the annual meeting of the American Academy of Dermatology.

©Vidmantas Goldbergas/iStockphoto.com

The risk increased as tanning bed use increased (Cancer Epidemiol. Biomarkers Prev. 2010;19:1557-68).

A more recent study demonstrated that with every visit to a tanning bed, the risk of melanoma increased by 1.8% – and the risk was even greater among those who started tanning at a younger age (BMJ 2012;345:e4757).

"We are clearly in the throes of a modern-day epidemic, particularly among teenage white girls and young women between the ages of 18 and 25," Mr. Geller said, noting that study after study shows that about a third of white teenage girls and about 20% of all teenage girls use a tanning bed by the age of 17.

And yet only five states restrict the use of tanning beds by those under age 18. Others have parental consent restrictions, but these have been shown to have no effect on tanning bed use by minors. That means that in 45 states, children aged 15 years and younger are free to visit tanning salons with no restrictions, he said, noting that a Washington University in St. Louis survey released in February showed that 65% of Missouri tanning salon owners would allow preteens aged 10-12 years to use their tanning beds – and that 43% of tanning salon employees believe indoor tanning poses no health risks.

Data show that 7% of girls use tanning beds by age 14 years. This doubles from age 14 to 15, and doubles again from age 15 to 17, he said, noting that girls are about five to six times more likely than boys to use tanning beds.

Of particular concern, not only are girls using tanning beds early, but they are using them more often.

A Centers for Disease Control and Prevention survey showed that while the rate of use (20% among all girls) has remained constant in recent years, the "prom phenomenon" – the occasional use of tanning beds before a special event – is no longer the norm; the average yearly number of uses of tanning beds among those surveyed was 28.

"We’re way past the prom phenomenon," Mr. Geller said, noting that one reason for this is that tanning salons "do a wonderful job of selling giant packages of use for very little money."

"When people are beginning to think of some kind of restrictions on the tanning bed industry, that would be one we could surely consider," he said, noting that based on the data showing a 1.8% increase in melanoma risk with each tanning bed use, the risk would be 54%-90% in a teen who starts tanning at age 18 and quits at age 19.

That’s a conservative estimate, because most teens start before age 18 and don’t stop at age 19, he said.

Surveillance, Epidemiology, and End Results (SEER) data from the National Cancer Institute show that the risk of melanoma has doubled among women aged 20-24 years since the 1980s, while the risk in men has declined in some age groups, and remained the same in others.

"You have to ask what’s happened during that time," Mr. Geller said, adding that there is concern about the late effects of tanning bed use, especially given that sun exposure time hasn’t changed in that age group over time.

As for what can be done from a public health perspective to reduce tanning bed use, Mr. Geller said a number of research, legislative, and public health campaigns are underway.

"We know from doing qualitative work, that indoor tanning is largely socially driven. "When [girls] are not tanning, they talk about tanning, they blog about tanning," he said, explaining that "the tanning culture involves some kind of socially driven bonds."

The key is to figure out how to break up those bonds.

"If one girl in a social group quits tanning, will this have an effect on the others? We don’t know," he said, adding that this is among the areas that require further research.

Researchers are also studying the effects of antitanning campaigns and legislation in other countries, a number of which have restricted access to tanning beds for minors. A recent web-based advertising campaign in Denmark targeted teens, and, along with legislation restricting access, resulted in a substantial drop in tanning bed use there, he said.

The results of campaigns and legislative efforts like these are being closely monitored so that the lessons learned about if and how they work can be incorporated into efforts here.

Lessons from the campaign against smoking launched three decades ago also are being incorporated into the current effort to reduce tanning, he said.

Although the link between tanning and melanoma isn’t quite as strong as the link between smoking and lung cancer, the seven key principles that made the antismoking campaign a success can be adapted for this purpose. These are surveillance, taxation, legal strategies, public health advertising campaigns, educational programs, legislation, and "some move to mandate enforcement," he said.

Some progress has been made with respect to these principles. For example, state-by-state surveillance and scoring of states’ level of compliance with existing regulations are underway, a 10% tax has been imposed on tanning salons, cost-efficacy studies are being planned, and lawsuits have been filed in multiple states. However, most of these efforts are in their infancy, Mr. Geller said.

For now, what exists across the United States is a "patchwork quilt of pretty crummy regulations," he said.

While intense pressure is on the Food and Drug Administration to ban tanning bed use by those under age 18 – including pressure from the American Academy of Dermatology – and while the agency is cognizant of the risks and has acknowledged a need for more regulations, "politics have prevailed, and at this point we don’t have the ban," he said.

The FDA website does, however, indicate plans for revising regulations and strengthening warning labels to make consumers more aware of the risks, he noted.

"This is good, but I think it’s a really faulty response to everything that we know about the link between tanning beds and melanoma," he said.

Despite the slow progress toward a ban for those under age 18, there have been some successes in the antitanning campaign. For one, numerous organizations have taken up the cause, including the World Health Organization, the American Academy of Pediatrics, the American Medical Association, the Society of Surgical Oncology, and the Canadian Pediatric Society.

Also, thanks to a Federal Trade Commission crackdown in 2010, the tanning industry is no longer allowed to claim that tanning has certain health benefits, such as reducing the risks of some types of cancers. And in 2012, the U.S. Preventive Services Task Force issued its first guidelines on tanning, stating that the evidence is strong enough to recommend that women aged 10-24 years who have fair skin should avoid prime-time sun exposure and tanning beds.

Additionally, a wellness provision of the Patient Protection and Affordable Care Act that will go into effect in May provides for full reimbursement to health care providers for counseling about skin cancer prevention and tanning bed reduction.

"We want to study this because we think this will have a huge effect on increasing the rate of counseling," he said.

Mr. Geller reported having no disclosures.

MAUI, HAWAII – Within the next year or two, two promising new topical medications may join the roster of products for managing rosacea, according to Dr. Joseph F. Fowler Jr.

The two coming attractions are brimonidine tartrate 0.5% gel and oxymetazoline cream. Brimonidine is further along in development; Galderma has submitted an application for Food and Drug Administration marketing approval of the product. Phase II studies of oxymetazoline cream are ongoing.

"Having seen both of these drugs in studies, I think both are going to be effective," said Dr. Fowler, of the University of Louisville (Ky.). "I have no idea if one will be more effective than the other, but I can tell you that both of them are probably going to be a lot better than anything else we have now for the erythema of rosacea," he noted.

"It usually takes around a year after that for a drug to reach the market, assuming no problems arise," Dr. Fowler said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/IMNG Medical Media

Both drugs are vasoconstrictors; they are already marketed in other formulations for indications other than rosacea. Oxymetazoline is used as a decongestant in some versions of Afrin nasal spray. Brimonidine is an alpha-2 agonist formulated as a prescription eye drop for the treatment of glaucoma, said Dr. Fowler, who was codirector of the seminar.

The only two topical therapies currently approved for treatment of rosacea – metronidazole and azelaic acid – don’t do much at all to improve the erythematous component of rosacea, in Dr. Fowler’s view. They do reduce inflammatory lesion counts, but not the background redness, he said.

In a separate presentation during the seminar, Dr. Guy W. Webster described his off-label experience in treating rosacea using oxymetazoline and brimonidine in their current formulations.

"These are two off-label products that really work," he said. "I have rosacea patients who are such spectacular flushers that they can’t go outside in the wintertime, but many of them do great with one of these two off-label medicines. It’s something to think about" when other efforts to improve erythema and flushing fail, said Dr. Webster of Thomas Jefferson University, Philadelphia.

Of the two products, the brimonidine eye drops work better when applied to the skin, said Dr. Webster. In fact, the eye drops are so effective that patients require careful instruction in off-label use or they will end up with white streaking on a background of untreated redness that may last for 4-8 hours, he said. Dr. Webster also recommends a preemptive phone call to a patient’s pharmacist to confirm that the "apply to cheeks" instruction on the prescription for the glaucoma medication is in fact correct.

Alternatively, the version of Afrin that contains oxymetazoline can be sprayed on the cheeks for temporary relief of rosacea. However, the investigational cream formulation works better, Dr. Webster said.

Dr. Webster also discussed the use of the two approved topical agents for rosacea and several other drugs with well-established off-label use.

Topical metronidazole 0.75% was the first the original concentration approved for rosacea, but the more recently approved 1% concentration is "vastly superior," in Dr. Webster’s view.

"Unfortunately, a lot of our insurers make patients get the old generic form, which I find is like a placebo," he noted.

Dr. Webster said that some of his patients respond to azelaic acid – the other FDA-approved topical drug – but not to metronidazole, and vice versa.

Topical benzoyl peroxide/clindamycin products often improve papular inflammatory rosacea, although the mechanism of action is unclear, he added.

Dr. Webster said he is unimpressed with the efficacy of sodium sulfacetamide/sulfur for rosacea. "For the amount of activity it gives, it’s almost not worth the expense," he said.

In Dr. Webster’s experience, tacrolimus and pimecrolimus are not useful in uncomplicated rosacea, but he said he finds the topical calcineurin inhibitors invaluable in patients whose rosacea is exacerbated by comorbid atopic dermatitis or seborrheic dermatitis.

"I find I can’t get the rosacea better when it’s being tweaked by a coexisting inflammatory disease unless I get the atopic dermatitis or seborrheic dermatitis better. These two drugs, off label, are critical to getting the rosacea to be able to respond because rosacea is provoked by other inflammation," he explained.

Dr. Webster serves as a consultant to half a dozen pharmaceutical companies, including Galderma and Allergan, which are developing brimonidine gel and oxymetazoline cream, respectively, as rosacea drugs.

Dr. Fowler is a consultant to multiple pharmaceutical companies, including Galderma, and is a research investigator for multiple companies including Galderma and Allergan.

SDEF and this news organization are owned by the same parent company.

[email protected]

MAUI, HAWAII – Within the next year or two, two promising new topical medications may join the roster of products for managing rosacea, according to Dr. Joseph F. Fowler Jr.

The two coming attractions are brimonidine tartrate 0.5% gel and oxymetazoline cream. Brimonidine is further along in development; Galderma has submitted an application for Food and Drug Administration marketing approval of the product. Phase II studies of oxymetazoline cream are ongoing.

"Having seen both of these drugs in studies, I think both are going to be effective," said Dr. Fowler, of the University of Louisville (Ky.). "I have no idea if one will be more effective than the other, but I can tell you that both of them are probably going to be a lot better than anything else we have now for the erythema of rosacea," he noted.

"It usually takes around a year after that for a drug to reach the market, assuming no problems arise," Dr. Fowler said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/IMNG Medical Media

Both drugs are vasoconstrictors; they are already marketed in other formulations for indications other than rosacea. Oxymetazoline is used as a decongestant in some versions of Afrin nasal spray. Brimonidine is an alpha-2 agonist formulated as a prescription eye drop for the treatment of glaucoma, said Dr. Fowler, who was codirector of the seminar.

The only two topical therapies currently approved for treatment of rosacea – metronidazole and azelaic acid – don’t do much at all to improve the erythematous component of rosacea, in Dr. Fowler’s view. They do reduce inflammatory lesion counts, but not the background redness, he said.

In a separate presentation during the seminar, Dr. Guy W. Webster described his off-label experience in treating rosacea using oxymetazoline and brimonidine in their current formulations.

"These are two off-label products that really work," he said. "I have rosacea patients who are such spectacular flushers that they can’t go outside in the wintertime, but many of them do great with one of these two off-label medicines. It’s something to think about" when other efforts to improve erythema and flushing fail, said Dr. Webster of Thomas Jefferson University, Philadelphia.

Of the two products, the brimonidine eye drops work better when applied to the skin, said Dr. Webster. In fact, the eye drops are so effective that patients require careful instruction in off-label use or they will end up with white streaking on a background of untreated redness that may last for 4-8 hours, he said. Dr. Webster also recommends a preemptive phone call to a patient’s pharmacist to confirm that the "apply to cheeks" instruction on the prescription for the glaucoma medication is in fact correct.

Alternatively, the version of Afrin that contains oxymetazoline can be sprayed on the cheeks for temporary relief of rosacea. However, the investigational cream formulation works better, Dr. Webster said.

Dr. Webster also discussed the use of the two approved topical agents for rosacea and several other drugs with well-established off-label use.

Topical metronidazole 0.75% was the first the original concentration approved for rosacea, but the more recently approved 1% concentration is "vastly superior," in Dr. Webster’s view.

"Unfortunately, a lot of our insurers make patients get the old generic form, which I find is like a placebo," he noted.

Dr. Webster said that some of his patients respond to azelaic acid – the other FDA-approved topical drug – but not to metronidazole, and vice versa.

Topical benzoyl peroxide/clindamycin products often improve papular inflammatory rosacea, although the mechanism of action is unclear, he added.

Dr. Webster said he is unimpressed with the efficacy of sodium sulfacetamide/sulfur for rosacea. "For the amount of activity it gives, it’s almost not worth the expense," he said.

In Dr. Webster’s experience, tacrolimus and pimecrolimus are not useful in uncomplicated rosacea, but he said he finds the topical calcineurin inhibitors invaluable in patients whose rosacea is exacerbated by comorbid atopic dermatitis or seborrheic dermatitis.

"I find I can’t get the rosacea better when it’s being tweaked by a coexisting inflammatory disease unless I get the atopic dermatitis or seborrheic dermatitis better. These two drugs, off label, are critical to getting the rosacea to be able to respond because rosacea is provoked by other inflammation," he explained.

Dr. Webster serves as a consultant to half a dozen pharmaceutical companies, including Galderma and Allergan, which are developing brimonidine gel and oxymetazoline cream, respectively, as rosacea drugs.

Dr. Fowler is a consultant to multiple pharmaceutical companies, including Galderma, and is a research investigator for multiple companies including Galderma and Allergan.

SDEF and this news organization are owned by the same parent company.

[email protected]

MAUI, HAWAII – Within the next year or two, two promising new topical medications may join the roster of products for managing rosacea, according to Dr. Joseph F. Fowler Jr.

The two coming attractions are brimonidine tartrate 0.5% gel and oxymetazoline cream. Brimonidine is further along in development; Galderma has submitted an application for Food and Drug Administration marketing approval of the product. Phase II studies of oxymetazoline cream are ongoing.

"Having seen both of these drugs in studies, I think both are going to be effective," said Dr. Fowler, of the University of Louisville (Ky.). "I have no idea if one will be more effective than the other, but I can tell you that both of them are probably going to be a lot better than anything else we have now for the erythema of rosacea," he noted.

"It usually takes around a year after that for a drug to reach the market, assuming no problems arise," Dr. Fowler said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/IMNG Medical Media

Both drugs are vasoconstrictors; they are already marketed in other formulations for indications other than rosacea. Oxymetazoline is used as a decongestant in some versions of Afrin nasal spray. Brimonidine is an alpha-2 agonist formulated as a prescription eye drop for the treatment of glaucoma, said Dr. Fowler, who was codirector of the seminar.

The only two topical therapies currently approved for treatment of rosacea – metronidazole and azelaic acid – don’t do much at all to improve the erythematous component of rosacea, in Dr. Fowler’s view. They do reduce inflammatory lesion counts, but not the background redness, he said.

In a separate presentation during the seminar, Dr. Guy W. Webster described his off-label experience in treating rosacea using oxymetazoline and brimonidine in their current formulations.

"These are two off-label products that really work," he said. "I have rosacea patients who are such spectacular flushers that they can’t go outside in the wintertime, but many of them do great with one of these two off-label medicines. It’s something to think about" when other efforts to improve erythema and flushing fail, said Dr. Webster of Thomas Jefferson University, Philadelphia.

Of the two products, the brimonidine eye drops work better when applied to the skin, said Dr. Webster. In fact, the eye drops are so effective that patients require careful instruction in off-label use or they will end up with white streaking on a background of untreated redness that may last for 4-8 hours, he said. Dr. Webster also recommends a preemptive phone call to a patient’s pharmacist to confirm that the "apply to cheeks" instruction on the prescription for the glaucoma medication is in fact correct.

Alternatively, the version of Afrin that contains oxymetazoline can be sprayed on the cheeks for temporary relief of rosacea. However, the investigational cream formulation works better, Dr. Webster said.

Dr. Webster also discussed the use of the two approved topical agents for rosacea and several other drugs with well-established off-label use.

Topical metronidazole 0.75% was the first the original concentration approved for rosacea, but the more recently approved 1% concentration is "vastly superior," in Dr. Webster’s view.

"Unfortunately, a lot of our insurers make patients get the old generic form, which I find is like a placebo," he noted.

Dr. Webster said that some of his patients respond to azelaic acid – the other FDA-approved topical drug – but not to metronidazole, and vice versa.

Topical benzoyl peroxide/clindamycin products often improve papular inflammatory rosacea, although the mechanism of action is unclear, he added.

Dr. Webster said he is unimpressed with the efficacy of sodium sulfacetamide/sulfur for rosacea. "For the amount of activity it gives, it’s almost not worth the expense," he said.

In Dr. Webster’s experience, tacrolimus and pimecrolimus are not useful in uncomplicated rosacea, but he said he finds the topical calcineurin inhibitors invaluable in patients whose rosacea is exacerbated by comorbid atopic dermatitis or seborrheic dermatitis.

"I find I can’t get the rosacea better when it’s being tweaked by a coexisting inflammatory disease unless I get the atopic dermatitis or seborrheic dermatitis better. These two drugs, off label, are critical to getting the rosacea to be able to respond because rosacea is provoked by other inflammation," he explained.

Dr. Webster serves as a consultant to half a dozen pharmaceutical companies, including Galderma and Allergan, which are developing brimonidine gel and oxymetazoline cream, respectively, as rosacea drugs.

Dr. Fowler is a consultant to multiple pharmaceutical companies, including Galderma, and is a research investigator for multiple companies including Galderma and Allergan.

SDEF and this news organization are owned by the same parent company.

[email protected]

MIAMI BEACH – Choosing the right laser and the correct parameters, along with proper patient selection and counseling, can reduce the risk of complications and promote safe and effective hair removal in skin of color patients, according to Dr. H. Ray Jalian of the University of California, Los Angeles.

Patient selection and counseling come first, Dr. Jalian said at the annual meeting of the American Academy of Dermatology. Explain to darker-skinned patients that they may need more treatments than patients with lighter skin (Fitzpatrick types I to III), he said.

Both the 800-810-nm long-pulsed diode laser and the long-pulsed 1064 Nd:YAG laser have proven safe and effective in laser hair removal in darker skin types, but Dr. Jalian said he prefers the long-pulsed 1064 Nd:YAG.

To improve safety, pay attention to the laser parameters, Dr. Jalian advised. Use longer wavelengths to ensure less melanin absorption, he said. In addition, the pulse duration should to be longer than the thermal relaxation time (TRT) of the epidermal melanosomes. For example, the TRT for a melanosome is 250 ns, and a typical laser pulse duration is 10-100 ns; the TRT for a terminal hair follicle is 100 ms, and a typical pulse duration is 3-100 ms, he said.

Before a procedure, Dr. Jalian advises his patients to use sun protection and to shave the area, because the burning hair can act like a "hot coal." He also puts patients on oral antibiotics if they report a history of pseudofolliculitis barbae flares.

In addition, "perform the procedure on a test spot that’s representative of the area for hair removal, and reevaluate it in 4 weeks before treating the entire area," said Dr. Jalian.

During the procedure, look for desired endpoints, including perifollicular erythema and singed hairs. But also look for undesired endpoints, including epidermal graying, blisters, and excessive pain, Dr. Jalian said.

He also recommended epidermal cooling to minimize epidermal damage caused by the absorption of light by melanin. Cooling strategies include using passive cooling methods such as cold gel, and using the cooling tools available on many lasers, such as the sapphire tip, cryogen spray, and forced chilled air, he added.

"And remember that there can be too much of a good thing," in terms of cooling, said Dr. Jalian. "There should be a balance between heating and cooling of the skin to achieve best results."

After a laser hair removal procedure, he recommends a single application of a midpotency topical steroid, and sun protection.

Common complications of laser hair removal in darker skin types include hyperpigmentation and hypopigmentation, infections and folliculitis, scarring, and eye injury. Dr. Jalian advised against using an Nd:YAG laser close to the orbit of the eye to reduce the odds of such an injury.

Paradoxical hypertrichosis after laser hair removal has been reported, mostly in darker skin types, and with all light sources. Some risk factors include Mediterranean, Middle Eastern, and Indian ethnicities, a low-set frontal hair line, and fine or intermediate hair. Subtherapeutic fluence also may cause induction of hair cycle at the edge of a laser spot, he said.

Dr. Jalian had no financial conflicts to disclose.

[email protected]

On Twitter @naseemsmiller

MIAMI BEACH – Choosing the right laser and the correct parameters, along with proper patient selection and counseling, can reduce the risk of complications and promote safe and effective hair removal in skin of color patients, according to Dr. H. Ray Jalian of the University of California, Los Angeles.

Patient selection and counseling come first, Dr. Jalian said at the annual meeting of the American Academy of Dermatology. Explain to darker-skinned patients that they may need more treatments than patients with lighter skin (Fitzpatrick types I to III), he said.

Both the 800-810-nm long-pulsed diode laser and the long-pulsed 1064 Nd:YAG laser have proven safe and effective in laser hair removal in darker skin types, but Dr. Jalian said he prefers the long-pulsed 1064 Nd:YAG.

To improve safety, pay attention to the laser parameters, Dr. Jalian advised. Use longer wavelengths to ensure less melanin absorption, he said. In addition, the pulse duration should to be longer than the thermal relaxation time (TRT) of the epidermal melanosomes. For example, the TRT for a melanosome is 250 ns, and a typical laser pulse duration is 10-100 ns; the TRT for a terminal hair follicle is 100 ms, and a typical pulse duration is 3-100 ms, he said.

Before a procedure, Dr. Jalian advises his patients to use sun protection and to shave the area, because the burning hair can act like a "hot coal." He also puts patients on oral antibiotics if they report a history of pseudofolliculitis barbae flares.

In addition, "perform the procedure on a test spot that’s representative of the area for hair removal, and reevaluate it in 4 weeks before treating the entire area," said Dr. Jalian.

During the procedure, look for desired endpoints, including perifollicular erythema and singed hairs. But also look for undesired endpoints, including epidermal graying, blisters, and excessive pain, Dr. Jalian said.

He also recommended epidermal cooling to minimize epidermal damage caused by the absorption of light by melanin. Cooling strategies include using passive cooling methods such as cold gel, and using the cooling tools available on many lasers, such as the sapphire tip, cryogen spray, and forced chilled air, he added.

"And remember that there can be too much of a good thing," in terms of cooling, said Dr. Jalian. "There should be a balance between heating and cooling of the skin to achieve best results."

After a laser hair removal procedure, he recommends a single application of a midpotency topical steroid, and sun protection.

Common complications of laser hair removal in darker skin types include hyperpigmentation and hypopigmentation, infections and folliculitis, scarring, and eye injury. Dr. Jalian advised against using an Nd:YAG laser close to the orbit of the eye to reduce the odds of such an injury.

Paradoxical hypertrichosis after laser hair removal has been reported, mostly in darker skin types, and with all light sources. Some risk factors include Mediterranean, Middle Eastern, and Indian ethnicities, a low-set frontal hair line, and fine or intermediate hair. Subtherapeutic fluence also may cause induction of hair cycle at the edge of a laser spot, he said.

Dr. Jalian had no financial conflicts to disclose.

[email protected]

On Twitter @naseemsmiller

MIAMI BEACH – Choosing the right laser and the correct parameters, along with proper patient selection and counseling, can reduce the risk of complications and promote safe and effective hair removal in skin of color patients, according to Dr. H. Ray Jalian of the University of California, Los Angeles.

Patient selection and counseling come first, Dr. Jalian said at the annual meeting of the American Academy of Dermatology. Explain to darker-skinned patients that they may need more treatments than patients with lighter skin (Fitzpatrick types I to III), he said.

Both the 800-810-nm long-pulsed diode laser and the long-pulsed 1064 Nd:YAG laser have proven safe and effective in laser hair removal in darker skin types, but Dr. Jalian said he prefers the long-pulsed 1064 Nd:YAG.

To improve safety, pay attention to the laser parameters, Dr. Jalian advised. Use longer wavelengths to ensure less melanin absorption, he said. In addition, the pulse duration should to be longer than the thermal relaxation time (TRT) of the epidermal melanosomes. For example, the TRT for a melanosome is 250 ns, and a typical laser pulse duration is 10-100 ns; the TRT for a terminal hair follicle is 100 ms, and a typical pulse duration is 3-100 ms, he said.

Before a procedure, Dr. Jalian advises his patients to use sun protection and to shave the area, because the burning hair can act like a "hot coal." He also puts patients on oral antibiotics if they report a history of pseudofolliculitis barbae flares.

In addition, "perform the procedure on a test spot that’s representative of the area for hair removal, and reevaluate it in 4 weeks before treating the entire area," said Dr. Jalian.

During the procedure, look for desired endpoints, including perifollicular erythema and singed hairs. But also look for undesired endpoints, including epidermal graying, blisters, and excessive pain, Dr. Jalian said.

He also recommended epidermal cooling to minimize epidermal damage caused by the absorption of light by melanin. Cooling strategies include using passive cooling methods such as cold gel, and using the cooling tools available on many lasers, such as the sapphire tip, cryogen spray, and forced chilled air, he added.

"And remember that there can be too much of a good thing," in terms of cooling, said Dr. Jalian. "There should be a balance between heating and cooling of the skin to achieve best results."

After a laser hair removal procedure, he recommends a single application of a midpotency topical steroid, and sun protection.

Common complications of laser hair removal in darker skin types include hyperpigmentation and hypopigmentation, infections and folliculitis, scarring, and eye injury. Dr. Jalian advised against using an Nd:YAG laser close to the orbit of the eye to reduce the odds of such an injury.

Paradoxical hypertrichosis after laser hair removal has been reported, mostly in darker skin types, and with all light sources. Some risk factors include Mediterranean, Middle Eastern, and Indian ethnicities, a low-set frontal hair line, and fine or intermediate hair. Subtherapeutic fluence also may cause induction of hair cycle at the edge of a laser spot, he said.

Dr. Jalian had no financial conflicts to disclose.

[email protected]

On Twitter @naseemsmiller

MIAMI BEACH – When it comes to procedures such as chemical peels, microdermabrasion, and laser therapies, one size doesn’t fit all, and dermatologists should take special precautions when treating patients with darker skin.

Dr. Marta Rendon, a dermatologist in Boca Raton, Florida, said she sees at least two patients a week who are seeking treatment for pigmentary complications that have been caused by prior cosmetic procedures performed by other physicians.

Some she can treat, and some are beyond repair.

"If I were to sum up my presentation, I would tell you that above all, be conservative and don’t be aggressive," especially in patients with ethnic skin, she told her audience at the annual meeting of the American Academy of Dermatology.

Dr. Rendon, who is also the president of the Skin of Color Society, urged physicians to take precautions because with the increasing diversity of the United States, their patient population is only going to get more diverse.

"Do the patient history. Take your time," advised Dr. Rendon. "Find out what their ethnic background is. Ask them about their grandmother, and where they are from."

The second most important part of history, she said, is asking about reaction to prior procedures or surgeries and prior history of postinflammatory hyperpigmentation (PIH).

"Ask them about what they do, what their hobbies are, or if they play a sport," she said. And take into account the season. During warmer temperatures, consider superficial peels and be careful with lasers. Medium peels and laser resurfacing are more appropriate during cooler and cloudier seasons, she said.

Take caution

Dr. Rendon had the following advice for various procedures in ethnic skin:

• Don’t perform chemical peels on patients on tretinoin. Don’t start with a high concentration. Don’t do excessive layers. And don’t combine surgical procedures with peels in the same visit.

• When performing microdermabrasion, don’t be too aggressive to avoid PIH, streaking, and scratch marks. Don\'t perform the procedure too close to the eyes. Avoid extremely sensitive skin and pressure urticaria. And always start with the lowest strength and time interval.

• With fillers, be careful with superficial placement since the colored material can be seen through the skin. Hyaluronic acid is safer, because it’s colorless and less risky to use. Be mindful that severe bruising can lead to hemosiderin. And be sure that all your patients are using sunscreen.

• For laser and light therapies, always do a test spot. Have a solid understanding of laser-tissue interaction. And be prepared if pigmentation problems develop, so that you can treat them early.

Treatment

Aggressive and early intervention is crucial in treating side effects from cosmetic procedures.

One of the keys to prevent hyperpigmentation is UV protection, whether it’s with sunscreens, cosmetics, antioxidants such as topical vitamin C and E, or systemic agents such as chloroquine, fish oil, or green-tea extract, said Dr. Rendon.

Several topical agents can be used to treat hyperpigmentation. They include hydroquinone, hydroquinone combination, glycolic/retinoid/steroid combination, or antioxidants.

Dr. Rendon also listed several combination bleaching agents including hydroquinone 4%, tretinoin 0.05%, and fluocinolone 0.01%; hydroquinone 4% and retinol 0.3%; hydroquinone microentrapped 4% and retinol 0.15%; hydroquinone and glycolic acid 10%; hydroquinone, glycolic acid 10% + and hyaluronic acid; mequinol and tretinoin 0.01%; retinaldehyde and glycolic acid; and compounded hydroquinone 6%-8%.

Niacinamide is one of the cosmeceutical skin-lightening agents that act as a vitamin exfoliant, reducing melanosome transfer. Soy-protease inhibitors and glutathione also have skin-lightening effects. Dr. Rendon also listed several skin lightening products including Melanozyme, Melaplex, Lumixyl (oligopeptide), retinaldehyde, lactic acid, ferrulic acid, and sunscreen.

She said her favorite method of treating pigmentary complications is to combine treatments. For instance, she combines peels with microdermabrasion; peels with laser; microdermabrasion with IPL; and fractional resurfacing with topical regimens. She added that she maximizes the procedures with topical regimens.

The bottom line is aggressive and early intervention for side effects, Dr. Rendon said.

As a result of growing ethnic population, the treatment options for pigmented skin is expanding, but in the meantime, dermatologists should ensure that their procedures are specific and individualized, Dr. Rendon advised.

"There’s no way of predicting who will hyperpigment, unless you take a good history," she said. And remember two pearls to stay out of trouble: Be conservative, and don’t use aggressive techniques.

Dr. Rendon has performed clinical research for and/or served as a consultant for several companies, including Amgen, Aveeno, Galderma, J&J, Neutrogena, and Sanofi-Aventis. She is a global spokesperson for the H&S brand.

[email protected]

On Twitter @naseemsmiller

MIAMI BEACH – When it comes to procedures such as chemical peels, microdermabrasion, and laser therapies, one size doesn’t fit all, and dermatologists should take special precautions when treating patients with darker skin.

Dr. Marta Rendon, a dermatologist in Boca Raton, Florida, said she sees at least two patients a week who are seeking treatment for pigmentary complications that have been caused by prior cosmetic procedures performed by other physicians.

Some she can treat, and some are beyond repair.

"If I were to sum up my presentation, I would tell you that above all, be conservative and don’t be aggressive," especially in patients with ethnic skin, she told her audience at the annual meeting of the American Academy of Dermatology.

Dr. Rendon, who is also the president of the Skin of Color Society, urged physicians to take precautions because with the increasing diversity of the United States, their patient population is only going to get more diverse.

"Do the patient history. Take your time," advised Dr. Rendon. "Find out what their ethnic background is. Ask them about their grandmother, and where they are from."

The second most important part of history, she said, is asking about reaction to prior procedures or surgeries and prior history of postinflammatory hyperpigmentation (PIH).

"Ask them about what they do, what their hobbies are, or if they play a sport," she said. And take into account the season. During warmer temperatures, consider superficial peels and be careful with lasers. Medium peels and laser resurfacing are more appropriate during cooler and cloudier seasons, she said.

Take caution

Dr. Rendon had the following advice for various procedures in ethnic skin:

• Don’t perform chemical peels on patients on tretinoin. Don’t start with a high concentration. Don’t do excessive layers. And don’t combine surgical procedures with peels in the same visit.

• When performing microdermabrasion, don’t be too aggressive to avoid PIH, streaking, and scratch marks. Don\'t perform the procedure too close to the eyes. Avoid extremely sensitive skin and pressure urticaria. And always start with the lowest strength and time interval.

• With fillers, be careful with superficial placement since the colored material can be seen through the skin. Hyaluronic acid is safer, because it’s colorless and less risky to use. Be mindful that severe bruising can lead to hemosiderin. And be sure that all your patients are using sunscreen.

• For laser and light therapies, always do a test spot. Have a solid understanding of laser-tissue interaction. And be prepared if pigmentation problems develop, so that you can treat them early.

Treatment

Aggressive and early intervention is crucial in treating side effects from cosmetic procedures.

One of the keys to prevent hyperpigmentation is UV protection, whether it’s with sunscreens, cosmetics, antioxidants such as topical vitamin C and E, or systemic agents such as chloroquine, fish oil, or green-tea extract, said Dr. Rendon.

Several topical agents can be used to treat hyperpigmentation. They include hydroquinone, hydroquinone combination, glycolic/retinoid/steroid combination, or antioxidants.

Dr. Rendon also listed several combination bleaching agents including hydroquinone 4%, tretinoin 0.05%, and fluocinolone 0.01%; hydroquinone 4% and retinol 0.3%; hydroquinone microentrapped 4% and retinol 0.15%; hydroquinone and glycolic acid 10%; hydroquinone, glycolic acid 10% + and hyaluronic acid; mequinol and tretinoin 0.01%; retinaldehyde and glycolic acid; and compounded hydroquinone 6%-8%.

Niacinamide is one of the cosmeceutical skin-lightening agents that act as a vitamin exfoliant, reducing melanosome transfer. Soy-protease inhibitors and glutathione also have skin-lightening effects. Dr. Rendon also listed several skin lightening products including Melanozyme, Melaplex, Lumixyl (oligopeptide), retinaldehyde, lactic acid, ferrulic acid, and sunscreen.

She said her favorite method of treating pigmentary complications is to combine treatments. For instance, she combines peels with microdermabrasion; peels with laser; microdermabrasion with IPL; and fractional resurfacing with topical regimens. She added that she maximizes the procedures with topical regimens.

The bottom line is aggressive and early intervention for side effects, Dr. Rendon said.

As a result of growing ethnic population, the treatment options for pigmented skin is expanding, but in the meantime, dermatologists should ensure that their procedures are specific and individualized, Dr. Rendon advised.

"There’s no way of predicting who will hyperpigment, unless you take a good history," she said. And remember two pearls to stay out of trouble: Be conservative, and don’t use aggressive techniques.

Dr. Rendon has performed clinical research for and/or served as a consultant for several companies, including Amgen, Aveeno, Galderma, J&J, Neutrogena, and Sanofi-Aventis. She is a global spokesperson for the H&S brand.

[email protected]

On Twitter @naseemsmiller

MIAMI BEACH – When it comes to procedures such as chemical peels, microdermabrasion, and laser therapies, one size doesn’t fit all, and dermatologists should take special precautions when treating patients with darker skin.

Dr. Marta Rendon, a dermatologist in Boca Raton, Florida, said she sees at least two patients a week who are seeking treatment for pigmentary complications that have been caused by prior cosmetic procedures performed by other physicians.

Some she can treat, and some are beyond repair.

"If I were to sum up my presentation, I would tell you that above all, be conservative and don’t be aggressive," especially in patients with ethnic skin, she told her audience at the annual meeting of the American Academy of Dermatology.

Dr. Rendon, who is also the president of the Skin of Color Society, urged physicians to take precautions because with the increasing diversity of the United States, their patient population is only going to get more diverse.

"Do the patient history. Take your time," advised Dr. Rendon. "Find out what their ethnic background is. Ask them about their grandmother, and where they are from."

The second most important part of history, she said, is asking about reaction to prior procedures or surgeries and prior history of postinflammatory hyperpigmentation (PIH).

"Ask them about what they do, what their hobbies are, or if they play a sport," she said. And take into account the season. During warmer temperatures, consider superficial peels and be careful with lasers. Medium peels and laser resurfacing are more appropriate during cooler and cloudier seasons, she said.

Take caution

Dr. Rendon had the following advice for various procedures in ethnic skin:

• Don’t perform chemical peels on patients on tretinoin. Don’t start with a high concentration. Don’t do excessive layers. And don’t combine surgical procedures with peels in the same visit.

• When performing microdermabrasion, don’t be too aggressive to avoid PIH, streaking, and scratch marks. Don\'t perform the procedure too close to the eyes. Avoid extremely sensitive skin and pressure urticaria. And always start with the lowest strength and time interval.

• With fillers, be careful with superficial placement since the colored material can be seen through the skin. Hyaluronic acid is safer, because it’s colorless and less risky to use. Be mindful that severe bruising can lead to hemosiderin. And be sure that all your patients are using sunscreen.

• For laser and light therapies, always do a test spot. Have a solid understanding of laser-tissue interaction. And be prepared if pigmentation problems develop, so that you can treat them early.

Treatment

Aggressive and early intervention is crucial in treating side effects from cosmetic procedures.

One of the keys to prevent hyperpigmentation is UV protection, whether it’s with sunscreens, cosmetics, antioxidants such as topical vitamin C and E, or systemic agents such as chloroquine, fish oil, or green-tea extract, said Dr. Rendon.

Several topical agents can be used to treat hyperpigmentation. They include hydroquinone, hydroquinone combination, glycolic/retinoid/steroid combination, or antioxidants.

Dr. Rendon also listed several combination bleaching agents including hydroquinone 4%, tretinoin 0.05%, and fluocinolone 0.01%; hydroquinone 4% and retinol 0.3%; hydroquinone microentrapped 4% and retinol 0.15%; hydroquinone and glycolic acid 10%; hydroquinone, glycolic acid 10% + and hyaluronic acid; mequinol and tretinoin 0.01%; retinaldehyde and glycolic acid; and compounded hydroquinone 6%-8%.

Niacinamide is one of the cosmeceutical skin-lightening agents that act as a vitamin exfoliant, reducing melanosome transfer. Soy-protease inhibitors and glutathione also have skin-lightening effects. Dr. Rendon also listed several skin lightening products including Melanozyme, Melaplex, Lumixyl (oligopeptide), retinaldehyde, lactic acid, ferrulic acid, and sunscreen.

She said her favorite method of treating pigmentary complications is to combine treatments. For instance, she combines peels with microdermabrasion; peels with laser; microdermabrasion with IPL; and fractional resurfacing with topical regimens. She added that she maximizes the procedures with topical regimens.

The bottom line is aggressive and early intervention for side effects, Dr. Rendon said.

As a result of growing ethnic population, the treatment options for pigmented skin is expanding, but in the meantime, dermatologists should ensure that their procedures are specific and individualized, Dr. Rendon advised.

"There’s no way of predicting who will hyperpigment, unless you take a good history," she said. And remember two pearls to stay out of trouble: Be conservative, and don’t use aggressive techniques.

Dr. Rendon has performed clinical research for and/or served as a consultant for several companies, including Amgen, Aveeno, Galderma, J&J, Neutrogena, and Sanofi-Aventis. She is a global spokesperson for the H&S brand.

[email protected]

On Twitter @naseemsmiller

The differences in facial structure, as well as differences in photoaging not discussed here, may be useful in the way we approach different aesthetic procedures sought by patients in different ethnic groups. Understanding these structural differences also may help us avoid a cookie-cutter approach and instead use aesthetic procedures to enhance each individual’s inherent beauty and what their ideals of beauty may be.

Beauty is subjective, but many have tried to measure beauty objectively by using anthropometry. Anthropometry is the quantitative measurement and ratio of facial features based on proportional relationships of the face known as the neoclassical canons. As proposed by Leonardo da Vinci, the ideal face can be divided into equal horizontal thirds: the distance from the frontal hairline to the top of the brow, from the brow to the base of the nose, and from the base of the nose to the inferior aspect of the chin. These mathematical facial proportions translate to a symmetrical oval or heart-shaped face, with prominent cheekbones, a tapered jaw line, a narrow nasal base, and thin lips.

Another method used to calculate beauty with mathematical proportions is the concept of "phi," the golden ratio. The ratio of 1:1.618 was described by ancient Greeks as a mathematical method to calculate optimal proportions for all structures in nature. Phi is the unique point on a line that divides the line into two lines in such a manner that the ratio of the smaller portion to the larger portion is the same as the ratio of the larger portion to the whole line.

Plastic surgeon Dr. Stephen Marquardt trademarked the "Phi mask," a facial mask of proportions that incorporates the 1:1.618 ratio to describe the mathematical ideal of an attractive face. The original Phi mask has been applied to persons of all races and ethnicities. However, Marquardt has modified it in recent years to apply to three different ethnic groups – Caucasian, Asian, and African – and he has noted the likelihood of more variations to come.

While phi proportions may be applied all ethnicities, baseline facial anatomic structural differences among different ethnicities exist. A study of facial analysis by Farkas et al. compared facial structure in African Americans with Caucasians (Aesthetic Plast. Surg. 2000;24:179-84). African Americans had a broader nasal base, decreased nasal projection, bimaxillary protrusion, orbital proptosis, increased soft tissue of the midface, prominent lips, and increased facial convexity. Given the interethnic variability in facial structure, other studies have identified two types of African-American nasal structure, one with a high dorsum and one with a low dorsum (Arch. Facial Plastic Surg. 2001;3:191-7).

Latino individuals reflect a range of ethnic backgrounds, but studies of Latina female facial structure generally have shown an increased bizygomatic distance, bimaxillary protrusion, a higher convexity angle, a broader nose, a broad rounded face, and a receding chin (Aesthetics and Cosmetic Surgery for Darker Skin Types, Lippincott Williams & Wilkins, 2007:10).

In persons of Mexican descent, studies show that the face is broader, with a prominent malar eminence, broad nose, widened alar base, short columella, horizontally oriented nostrils, and thick nasal skin (Clin. Plast. Surg. 1977;4:89-102; Aesthetic Plast. Surg. 1980;4:169-77). In Caribbean women, the anthropometric measurements are more similar to those of African American women than to those of Central and South American women, whose anthropometric measurements are closer to those of Caucasian women (Arch. Otolaryngol. Head Neck Surg. 1996;122:1079-86; Laryngoscope 1988;98:202-8).

Shirakabe et al. described the facial structure and soft tissue of persons of Asian descent as including a wider and rounder face, higher eyebrow, fuller upper lid, lower nasal bridge with horizontally placed flared ala, flatter malar prominence and midface, more protuberant lips, and more receded chin (Aesthetic Plast. Surg. 2003;27:397-402). The distance from the eyebrow to the upper-lid margin in Asians is much greater than in Caucasians due to the fuller upper eyelid and to the narrower palpebral fissure (Aesthetic Surg. J. 2003;23:170-76). There is also more malar fat in the midface of Asians, moderate premaxillary deficiency, and more prominent soft tissue in the lips compared with the thinner lips and more prominent chin often seen in Caucasians (Cosmetic Surgery of the Asian Face, Thieme Medical Publishers, New York, 1990).

Of course, such studies are limited by the use of one term to describe a large group of people encompassing many different countries and cultures that have different facial features and structures that distinguish them, but these are the data available thus far.

A recent study by Biller and Kim characterizing the ideal nasolabial angle, nasal tip width, and location of eyebrow apex for Asian and white women showed that neither the ethnicity of the model nor the ethnicity of the volunteer evaluating the model played a significant role in determining the ideal angle or position of the above parameters. The researchers found that, in general, a more lateral brow apex was preferable in younger faces, whereas a more medial apex was preferred in older faces. In addition, moderate nasolabial angles of 104 and 108 degrees and a nasal tip width of 35% of the alar base was most attractive in both ethnicities. The study supports some claims that beauty is considered to be innate and independent of ethnicity (Arch. Facial Plast. Surg. 2009;11:91-7). However, the study is limited by the small number of models (four), representing only two ethnicities. In addition, all of the volunteers evaluating the models were from the United States, which may represent a more "Westernized" ideal of beauty.

This column is adapted from "Evaluation of Beauty and the Aging Face," in Dermatology, 3rd ed., 2012, Elsevier Saunders, chapter 152; and from Semin. Cutan. Med. Surg. 2009;28:115-29.

Dr. Wesley practices dermatology in Beverly Hills, Calif. To read this column online, visit edermatologynews.com. Do you have questions about treating patients with dark skin? If so, send them to [email protected].

The differences in facial structure, as well as differences in photoaging not discussed here, may be useful in the way we approach different aesthetic procedures sought by patients in different ethnic groups. Understanding these structural differences also may help us avoid a cookie-cutter approach and instead use aesthetic procedures to enhance each individual’s inherent beauty and what their ideals of beauty may be.

Beauty is subjective, but many have tried to measure beauty objectively by using anthropometry. Anthropometry is the quantitative measurement and ratio of facial features based on proportional relationships of the face known as the neoclassical canons. As proposed by Leonardo da Vinci, the ideal face can be divided into equal horizontal thirds: the distance from the frontal hairline to the top of the brow, from the brow to the base of the nose, and from the base of the nose to the inferior aspect of the chin. These mathematical facial proportions translate to a symmetrical oval or heart-shaped face, with prominent cheekbones, a tapered jaw line, a narrow nasal base, and thin lips.

Another method used to calculate beauty with mathematical proportions is the concept of "phi," the golden ratio. The ratio of 1:1.618 was described by ancient Greeks as a mathematical method to calculate optimal proportions for all structures in nature. Phi is the unique point on a line that divides the line into two lines in such a manner that the ratio of the smaller portion to the larger portion is the same as the ratio of the larger portion to the whole line.

Plastic surgeon Dr. Stephen Marquardt trademarked the "Phi mask," a facial mask of proportions that incorporates the 1:1.618 ratio to describe the mathematical ideal of an attractive face. The original Phi mask has been applied to persons of all races and ethnicities. However, Marquardt has modified it in recent years to apply to three different ethnic groups – Caucasian, Asian, and African – and he has noted the likelihood of more variations to come.

While phi proportions may be applied all ethnicities, baseline facial anatomic structural differences among different ethnicities exist. A study of facial analysis by Farkas et al. compared facial structure in African Americans with Caucasians (Aesthetic Plast. Surg. 2000;24:179-84). African Americans had a broader nasal base, decreased nasal projection, bimaxillary protrusion, orbital proptosis, increased soft tissue of the midface, prominent lips, and increased facial convexity. Given the interethnic variability in facial structure, other studies have identified two types of African-American nasal structure, one with a high dorsum and one with a low dorsum (Arch. Facial Plastic Surg. 2001;3:191-7).

Latino individuals reflect a range of ethnic backgrounds, but studies of Latina female facial structure generally have shown an increased bizygomatic distance, bimaxillary protrusion, a higher convexity angle, a broader nose, a broad rounded face, and a receding chin (Aesthetics and Cosmetic Surgery for Darker Skin Types, Lippincott Williams & Wilkins, 2007:10).

In persons of Mexican descent, studies show that the face is broader, with a prominent malar eminence, broad nose, widened alar base, short columella, horizontally oriented nostrils, and thick nasal skin (Clin. Plast. Surg. 1977;4:89-102; Aesthetic Plast. Surg. 1980;4:169-77). In Caribbean women, the anthropometric measurements are more similar to those of African American women than to those of Central and South American women, whose anthropometric measurements are closer to those of Caucasian women (Arch. Otolaryngol. Head Neck Surg. 1996;122:1079-86; Laryngoscope 1988;98:202-8).

Shirakabe et al. described the facial structure and soft tissue of persons of Asian descent as including a wider and rounder face, higher eyebrow, fuller upper lid, lower nasal bridge with horizontally placed flared ala, flatter malar prominence and midface, more protuberant lips, and more receded chin (Aesthetic Plast. Surg. 2003;27:397-402). The distance from the eyebrow to the upper-lid margin in Asians is much greater than in Caucasians due to the fuller upper eyelid and to the narrower palpebral fissure (Aesthetic Surg. J. 2003;23:170-76). There is also more malar fat in the midface of Asians, moderate premaxillary deficiency, and more prominent soft tissue in the lips compared with the thinner lips and more prominent chin often seen in Caucasians (Cosmetic Surgery of the Asian Face, Thieme Medical Publishers, New York, 1990).

Of course, such studies are limited by the use of one term to describe a large group of people encompassing many different countries and cultures that have different facial features and structures that distinguish them, but these are the data available thus far.

A recent study by Biller and Kim characterizing the ideal nasolabial angle, nasal tip width, and location of eyebrow apex for Asian and white women showed that neither the ethnicity of the model nor the ethnicity of the volunteer evaluating the model played a significant role in determining the ideal angle or position of the above parameters. The researchers found that, in general, a more lateral brow apex was preferable in younger faces, whereas a more medial apex was preferred in older faces. In addition, moderate nasolabial angles of 104 and 108 degrees and a nasal tip width of 35% of the alar base was most attractive in both ethnicities. The study supports some claims that beauty is considered to be innate and independent of ethnicity (Arch. Facial Plast. Surg. 2009;11:91-7). However, the study is limited by the small number of models (four), representing only two ethnicities. In addition, all of the volunteers evaluating the models were from the United States, which may represent a more "Westernized" ideal of beauty.

This column is adapted from "Evaluation of Beauty and the Aging Face," in Dermatology, 3rd ed., 2012, Elsevier Saunders, chapter 152; and from Semin. Cutan. Med. Surg. 2009;28:115-29.

Dr. Wesley practices dermatology in Beverly Hills, Calif. To read this column online, visit edermatologynews.com. Do you have questions about treating patients with dark skin? If so, send them to [email protected].

The differences in facial structure, as well as differences in photoaging not discussed here, may be useful in the way we approach different aesthetic procedures sought by patients in different ethnic groups. Understanding these structural differences also may help us avoid a cookie-cutter approach and instead use aesthetic procedures to enhance each individual’s inherent beauty and what their ideals of beauty may be.

Beauty is subjective, but many have tried to measure beauty objectively by using anthropometry. Anthropometry is the quantitative measurement and ratio of facial features based on proportional relationships of the face known as the neoclassical canons. As proposed by Leonardo da Vinci, the ideal face can be divided into equal horizontal thirds: the distance from the frontal hairline to the top of the brow, from the brow to the base of the nose, and from the base of the nose to the inferior aspect of the chin. These mathematical facial proportions translate to a symmetrical oval or heart-shaped face, with prominent cheekbones, a tapered jaw line, a narrow nasal base, and thin lips.

Another method used to calculate beauty with mathematical proportions is the concept of "phi," the golden ratio. The ratio of 1:1.618 was described by ancient Greeks as a mathematical method to calculate optimal proportions for all structures in nature. Phi is the unique point on a line that divides the line into two lines in such a manner that the ratio of the smaller portion to the larger portion is the same as the ratio of the larger portion to the whole line.

Plastic surgeon Dr. Stephen Marquardt trademarked the "Phi mask," a facial mask of proportions that incorporates the 1:1.618 ratio to describe the mathematical ideal of an attractive face. The original Phi mask has been applied to persons of all races and ethnicities. However, Marquardt has modified it in recent years to apply to three different ethnic groups – Caucasian, Asian, and African – and he has noted the likelihood of more variations to come.

While phi proportions may be applied all ethnicities, baseline facial anatomic structural differences among different ethnicities exist. A study of facial analysis by Farkas et al. compared facial structure in African Americans with Caucasians (Aesthetic Plast. Surg. 2000;24:179-84). African Americans had a broader nasal base, decreased nasal projection, bimaxillary protrusion, orbital proptosis, increased soft tissue of the midface, prominent lips, and increased facial convexity. Given the interethnic variability in facial structure, other studies have identified two types of African-American nasal structure, one with a high dorsum and one with a low dorsum (Arch. Facial Plastic Surg. 2001;3:191-7).

Latino individuals reflect a range of ethnic backgrounds, but studies of Latina female facial structure generally have shown an increased bizygomatic distance, bimaxillary protrusion, a higher convexity angle, a broader nose, a broad rounded face, and a receding chin (Aesthetics and Cosmetic Surgery for Darker Skin Types, Lippincott Williams & Wilkins, 2007:10).

In persons of Mexican descent, studies show that the face is broader, with a prominent malar eminence, broad nose, widened alar base, short columella, horizontally oriented nostrils, and thick nasal skin (Clin. Plast. Surg. 1977;4:89-102; Aesthetic Plast. Surg. 1980;4:169-77). In Caribbean women, the anthropometric measurements are more similar to those of African American women than to those of Central and South American women, whose anthropometric measurements are closer to those of Caucasian women (Arch. Otolaryngol. Head Neck Surg. 1996;122:1079-86; Laryngoscope 1988;98:202-8).

Shirakabe et al. described the facial structure and soft tissue of persons of Asian descent as including a wider and rounder face, higher eyebrow, fuller upper lid, lower nasal bridge with horizontally placed flared ala, flatter malar prominence and midface, more protuberant lips, and more receded chin (Aesthetic Plast. Surg. 2003;27:397-402). The distance from the eyebrow to the upper-lid margin in Asians is much greater than in Caucasians due to the fuller upper eyelid and to the narrower palpebral fissure (Aesthetic Surg. J. 2003;23:170-76). There is also more malar fat in the midface of Asians, moderate premaxillary deficiency, and more prominent soft tissue in the lips compared with the thinner lips and more prominent chin often seen in Caucasians (Cosmetic Surgery of the Asian Face, Thieme Medical Publishers, New York, 1990).

Of course, such studies are limited by the use of one term to describe a large group of people encompassing many different countries and cultures that have different facial features and structures that distinguish them, but these are the data available thus far.

A recent study by Biller and Kim characterizing the ideal nasolabial angle, nasal tip width, and location of eyebrow apex for Asian and white women showed that neither the ethnicity of the model nor the ethnicity of the volunteer evaluating the model played a significant role in determining the ideal angle or position of the above parameters. The researchers found that, in general, a more lateral brow apex was preferable in younger faces, whereas a more medial apex was preferred in older faces. In addition, moderate nasolabial angles of 104 and 108 degrees and a nasal tip width of 35% of the alar base was most attractive in both ethnicities. The study supports some claims that beauty is considered to be innate and independent of ethnicity (Arch. Facial Plast. Surg. 2009;11:91-7). However, the study is limited by the small number of models (four), representing only two ethnicities. In addition, all of the volunteers evaluating the models were from the United States, which may represent a more "Westernized" ideal of beauty.

This column is adapted from "Evaluation of Beauty and the Aging Face," in Dermatology, 3rd ed., 2012, Elsevier Saunders, chapter 152; and from Semin. Cutan. Med. Surg. 2009;28:115-29.

Dr. Wesley practices dermatology in Beverly Hills, Calif. To read this column online, visit edermatologynews.com. Do you have questions about treating patients with dark skin? If so, send them to [email protected].

Discovered in nature in 1985 (Science 1992;257:215-7), fullerenes are novel, classically engineered chemical compounds composed only of carbon atoms. The stable form, a third carbon allotrope, is a molecule made up of 60 carbon atoms in a structure resembling a soccer ball or geodesic dome, although some fullerenes are ellipsoid or tube shaped. In fact, fullerene C(60), the first of the group of compounds to be discovered, is also known as buckminsterfullerene, based on Buckminster Fuller’s geodesic dome. The carbon nanotube structure, composed of thin carbon filaments (1-3 mcm in length and 1-3 nm in diameter) and possessing a wide range of mechanical characteristics, was discovered in 1991 (J. Nanosci. Nanotechnol. 2006;6:591-9).

The potential applications of C(60) and fullerene derivatives have been extensively studied, and recent data suggest that fullerenes exhibit potent antioxidant activity, even acting as a "free radical sponge" (Bioorg. Med. Chem. Lett. 2006;16:1590-5; Biomaterials 2008;29:3561-73). Therefore, fullerenes may be appropriate active ingredients for various skin care products, particularly rejuvenation products (Recent Pat. Biotechnol. 2011;5:67-73; Recent. Pat. Biotechnol. 2009;3:118-23).

Courtesy Wikimedia Commons/Jynto/Creative Commons Licesnse

Early studies

In one of the early studies of topical applications of fullerenes (C60), Nelson et al. examined the potential acute and subchronic toxic effects of fullerenes (200 mcg) applied in benzene on mouse skin. After 72 hours, they observed no effect on either DNA synthesis or ornithine decarboxylase activity. A skin tumor initiation model using 7,12-dimethylbenzanthracene (DMBA) failed to show benign or malignant skin tumor formation, but promotion using 12-O-tetradecanoyl-phorbol-13-acetate (TPA) resulted in benign skin tumors. The investigators concluded that fullerenes applied in benzene at a likely industrial exposure level did not cause acute toxic effects in mice (Toxicol. Ind. Health. 1993;9:623-30).

In 1997, Tabata et al., noted that fullerene C(60) efficiently generates singlet oxygen when irradiated with light, and found that polyethylene glycol (PEG)-modified C60 exhibits potential as an agent for photodynamic tumor therapy (Jpn. J. Cancer Res. 1997;88:1108-16).

Antiviral capacity

Fullerenes exhibit unique chemical and physical properties, including photodynamic characteristics and a hydrophobic spheroid and radical sponge quality. They also display antiviral activity, particularly in relation to HIV, and their potential commercial applications include use in patent-pending anticancer drug delivery systems employing photodynamic therapy (PDT), HIV drugs, and antiaging cosmetics (Int. J. Nanomedicine 2007;2:639-49).

Anti-inflammatory activity

An anti-inflammatory role has also been identified for fullerenes. Ryan et al. noted that preincubation with C(60) resulted in significant suppression of IgE-dependent mediator release in human mast cells and peripheral blood basophils. IgE-induced increases in cytoplasmic reactive oxygen species (ROS) levels was also hindered by preincubation with fullerenes. Using a mast cell–dependent anaphylaxis model, Ryan and colleagues also found that fullerenes prevented the in vivo release of histamine and fall in core body temperature. They concluded that fullerenes might suggest an innovative approach to managing mast cell–dependent conditions such as asthma, heart disease, inflammatory arthritis, and multiple sclerosis (J. Immunol. 2007;179(1):665-72).

Antimicrobial potential

In 2005, Tegos et al. compared the antimicrobial activity of six C(60) compounds functionalized with one, two, or three hydrophilic or cationic groups combined with white light against gram-positive and negative bacteria, and fungi. They found that following 10 minutes of incubation, bis- and tris-cationic fullerenes actively eliminated all tested microbes while leaving mammalian cells comparatively intact. The investigators also noted that the fullerene compounds were significantly more effective than a widely used antimicrobial photosensitizer, toluidine blue O. They concluded that the compounds warrant consideration as photosensitizers for antimicrobial use given their high selectivity and efficacy (Chem. Biol. 2005;12(10):1127-35).

Potent antioxidant

In 2006, Xiao et al. reported on their development of the Radical Sponge, a fullerene entrapped in polyvinylpyrrolidone to yield a water-soluble derivative with a mean particle diameter of about 688 nm and reactive oxygen species (ROS) scavenging abilities. The researchers repeatedly irradiated human skin keratinocytes (HaCaT) with visible light (400-2,000 nm) in the presence or absence of Radical Sponge, with no photocytotoxicity apparent in the Radical Sponge–exposed cells. In addition, the water-soluble fullerene derivative displayed a cytoprotective effect (10-40 mcM doses) against UVA exposure (30 J/cm²) when it was administered prior to exposure and rinsed out immediately before the irradiation, more so than when administered only during or after irradiation. The researchers concluded that this finding suggested more of a preventive as opposed to therapeutic effect conferred by Radical Sponge against UVA damage (Bioorg. Med. Chem. Lett. 2006;16:1590-5).

In a subsequent study, the researchers compared the Radical Sponge with two whitening agents and found the fullerene to have imparted stronger antimelanogenic activity, possibly due to down-regulation of the tyrosinase expression promoted by UVA-induced ROS generation (Arch. Dermatol. Res. 2007;299(5-6):245-57).

More recently, Kato et al. demonstrated the antioxidant activity of C(60) incorporated into liposomes, with persistent scavenging of hydroxyl radicals and cytoprotection of keratinocytes against UVA- and UVB-induced damage ascribed to the fullerene component (J. Nanosci. Nanotechnol. 2011;11(5):3814-23).

Safety

The first study establishing the safety of highly purified fullerenes (HPFs) as an additive in cosmeceuticals was conducted in 2009. Aoshima et al. performed in vivo tests in animals and in vitro examinations using human epidermal keratinocytes and fibroblasts. No primary or cumulative skin irritation, sensitization, photosensitization, or contact phototoxicity was observed. In the patch test on human skin, no reaction was noted. HPFs were deemed to be "minimally irritating" after the eye-irritation test in rabbits. The investigators concluded, based on their findings and in light of previously published data, that HPFs are safe for human skin as ingredients in cosmetic skin care formulations (J. Toxicol. Sci. 2009;34(5):555-62).

Hair regrowth

In 2009, Zhou et al. used shaved mice and SKH-1 hairless mice to study whether fullerene-based compounds could elicit hair growth. Fullerenes were found to significantly increase the hair growth rate compared with a placebo vehicle. Significantly increased numbers of hair follicles were also observed in SKH-1 hairless mice treated topically or subdermally with fullerenes. Cultured human skin treated with fullerenes also showed augmented hair growth. The data suggested implications for hair loss due to alopecia, chemotherapy, or other chemical reactions (Nanomedicine 2009;5:202-7).

Antiacne properties

In 2011, Inui et al. conducted an open trial of effects of fullerene gel on acne. Subjects used the gel twice daily, and significant reductions in the mean number of inflammatory lesions were noted at 4 and 8 weeks of treatment. In addition, the researchers conducted in vitro assays of sebum production in hamster sebocytes and found that 75 mcM polyvinylpyrrolidone-fullerene suppressed sebum production, suggesting that topical fullerenes inhibit acne by reducing neutrophil infiltration and sebum production (Nanomedicine 2011;7:238-41).

Water solubility and photodynamic activity

In 2007, Mroz et al. compared the photodynamic activity of six fullerenes functionalized to become soluble with 1, 2, or 3 hydrophilic or 1, 2, or 3 cationic groups in three mouse cancer cell lines (J774, LLC, and CT26) incubated for 24 hours with fullerenes and illuminated with white light. They found that some functionalized fullerenes (particularly monopyrrolidinium fullerene) induced apoptosis in all cancer lines (Free Radic. Biol. Med. 2007;43:711-9). In a subsequent study, Mroz et al. found that some fullerenes can be functionalized to photoinactivate pathogenic malignant cancer cells and/or microbial cells in a mechanism that involves superoxide anion and singlet oxygen. The researchers suggested that fullerenes have the potential to supersede photosensitizers in current clinical use in PDT for some conditions (Photochem. Photobiol. Sci. 2007;6:1139-49).

In 2009, Yin et al. showed that three different functionalized water-soluble fullerenes can intercept and protect cells against all of the primary physiologically important ROS and can efficiently suppress lipid peroxidation in vitro. The findings suggest the potential of fullerene derivatives as effective cytoprotective therapeutic agents (Biomaterials. 2009;30:611-21), the researchers wrote.

Conclusion

The discovery of the fullerene family has stimulated widespread research in chemistry and biology for a broad range of therapeutic applications. Anti-inflammatory, antioxidant, and antiviral activities have been linked to these compounds. In addition, fullerenes appear to be effective in drug and gene delivery and as an adjunct in acne therapy. The compounds have shown potential as photoprotectants as well as photosensitizers, which may be useful in photodynamic therapy. More research is needed, but the potential applications of fullerenes in dermatology are promising, particularly as potent antioxidants conferring skin protection.

Dr. Baumann is in private practice in Miami Beach. She did not disclose any conflicts of interest.

Courtesy Wikimedia Commons/Jynto/Creative Commons Licesnse

Discovered in nature in 1985 (Science 1992;257:215-7), fullerenes are novel, classically engineered chemical compounds composed only of carbon atoms. The stable form, a third carbon allotrope, is a molecule made up of 60 carbon atoms in a structure resembling a soccer ball or geodesic dome, although some fullerenes are ellipsoid or tube shaped. In fact, fullerene C(60), the first of the group of compounds to be discovered, is also known as buckminsterfullerene, based on Buckminster Fuller’s geodesic dome. The carbon nanotube structure, composed of thin carbon filaments (1-3 mcm in length and 1-3 nm in diameter) and possessing a wide range of mechanical characteristics, was discovered in 1991 (J. Nanosci. Nanotechnol. 2006;6:591-9).

The potential applications of C(60) and fullerene derivatives have been extensively studied, and recent data suggest that fullerenes exhibit potent antioxidant activity, even acting as a "free radical sponge" (Bioorg. Med. Chem. Lett. 2006;16:1590-5; Biomaterials 2008;29:3561-73). Therefore, fullerenes may be appropriate active ingredients for various skin care products, particularly rejuvenation products (Recent Pat. Biotechnol. 2011;5:67-73; Recent. Pat. Biotechnol. 2009;3:118-23).

Courtesy Wikimedia Commons/Jynto/Creative Commons Licesnse

Early studies

In one of the early studies of topical applications of fullerenes (C60), Nelson et al. examined the potential acute and subchronic toxic effects of fullerenes (200 mcg) applied in benzene on mouse skin. After 72 hours, they observed no effect on either DNA synthesis or ornithine decarboxylase activity. A skin tumor initiation model using 7,12-dimethylbenzanthracene (DMBA) failed to show benign or malignant skin tumor formation, but promotion using 12-O-tetradecanoyl-phorbol-13-acetate (TPA) resulted in benign skin tumors. The investigators concluded that fullerenes applied in benzene at a likely industrial exposure level did not cause acute toxic effects in mice (Toxicol. Ind. Health. 1993;9:623-30).

In 1997, Tabata et al., noted that fullerene C(60) efficiently generates singlet oxygen when irradiated with light, and found that polyethylene glycol (PEG)-modified C60 exhibits potential as an agent for photodynamic tumor therapy (Jpn. J. Cancer Res. 1997;88:1108-16).

Antiviral capacity

Fullerenes exhibit unique chemical and physical properties, including photodynamic characteristics and a hydrophobic spheroid and radical sponge quality. They also display antiviral activity, particularly in relation to HIV, and their potential commercial applications include use in patent-pending anticancer drug delivery systems employing photodynamic therapy (PDT), HIV drugs, and antiaging cosmetics (Int. J. Nanomedicine 2007;2:639-49).

Anti-inflammatory activity

An anti-inflammatory role has also been identified for fullerenes. Ryan et al. noted that preincubation with C(60) resulted in significant suppression of IgE-dependent mediator release in human mast cells and peripheral blood basophils. IgE-induced increases in cytoplasmic reactive oxygen species (ROS) levels was also hindered by preincubation with fullerenes. Using a mast cell–dependent anaphylaxis model, Ryan and colleagues also found that fullerenes prevented the in vivo release of histamine and fall in core body temperature. They concluded that fullerenes might suggest an innovative approach to managing mast cell–dependent conditions such as asthma, heart disease, inflammatory arthritis, and multiple sclerosis (J. Immunol. 2007;179(1):665-72).

Antimicrobial potential

In 2005, Tegos et al. compared the antimicrobial activity of six C(60) compounds functionalized with one, two, or three hydrophilic or cationic groups combined with white light against gram-positive and negative bacteria, and fungi. They found that following 10 minutes of incubation, bis- and tris-cationic fullerenes actively eliminated all tested microbes while leaving mammalian cells comparatively intact. The investigators also noted that the fullerene compounds were significantly more effective than a widely used antimicrobial photosensitizer, toluidine blue O. They concluded that the compounds warrant consideration as photosensitizers for antimicrobial use given their high selectivity and efficacy (Chem. Biol. 2005;12(10):1127-35).

Potent antioxidant

In 2006, Xiao et al. reported on their development of the Radical Sponge, a fullerene entrapped in polyvinylpyrrolidone to yield a water-soluble derivative with a mean particle diameter of about 688 nm and reactive oxygen species (ROS) scavenging abilities. The researchers repeatedly irradiated human skin keratinocytes (HaCaT) with visible light (400-2,000 nm) in the presence or absence of Radical Sponge, with no photocytotoxicity apparent in the Radical Sponge–exposed cells. In addition, the water-soluble fullerene derivative displayed a cytoprotective effect (10-40 mcM doses) against UVA exposure (30 J/cm²) when it was administered prior to exposure and rinsed out immediately before the irradiation, more so than when administered only during or after irradiation. The researchers concluded that this finding suggested more of a preventive as opposed to therapeutic effect conferred by Radical Sponge against UVA damage (Bioorg. Med. Chem. Lett. 2006;16:1590-5).

In a subsequent study, the researchers compared the Radical Sponge with two whitening agents and found the fullerene to have imparted stronger antimelanogenic activity, possibly due to down-regulation of the tyrosinase expression promoted by UVA-induced ROS generation (Arch. Dermatol. Res. 2007;299(5-6):245-57).

More recently, Kato et al. demonstrated the antioxidant activity of C(60) incorporated into liposomes, with persistent scavenging of hydroxyl radicals and cytoprotection of keratinocytes against UVA- and UVB-induced damage ascribed to the fullerene component (J. Nanosci. Nanotechnol. 2011;11(5):3814-23).

Safety

The first study establishing the safety of highly purified fullerenes (HPFs) as an additive in cosmeceuticals was conducted in 2009. Aoshima et al. performed in vivo tests in animals and in vitro examinations using human epidermal keratinocytes and fibroblasts. No primary or cumulative skin irritation, sensitization, photosensitization, or contact phototoxicity was observed. In the patch test on human skin, no reaction was noted. HPFs were deemed to be "minimally irritating" after the eye-irritation test in rabbits. The investigators concluded, based on their findings and in light of previously published data, that HPFs are safe for human skin as ingredients in cosmetic skin care formulations (J. Toxicol. Sci. 2009;34(5):555-62).

Hair regrowth

In 2009, Zhou et al. used shaved mice and SKH-1 hairless mice to study whether fullerene-based compounds could elicit hair growth. Fullerenes were found to significantly increase the hair growth rate compared with a placebo vehicle. Significantly increased numbers of hair follicles were also observed in SKH-1 hairless mice treated topically or subdermally with fullerenes. Cultured human skin treated with fullerenes also showed augmented hair growth. The data suggested implications for hair loss due to alopecia, chemotherapy, or other chemical reactions (Nanomedicine 2009;5:202-7).

Antiacne properties

In 2011, Inui et al. conducted an open trial of effects of fullerene gel on acne. Subjects used the gel twice daily, and significant reductions in the mean number of inflammatory lesions were noted at 4 and 8 weeks of treatment. In addition, the researchers conducted in vitro assays of sebum production in hamster sebocytes and found that 75 mcM polyvinylpyrrolidone-fullerene suppressed sebum production, suggesting that topical fullerenes inhibit acne by reducing neutrophil infiltration and sebum production (Nanomedicine 2011;7:238-41).

Water solubility and photodynamic activity

In 2007, Mroz et al. compared the photodynamic activity of six fullerenes functionalized to become soluble with 1, 2, or 3 hydrophilic or 1, 2, or 3 cationic groups in three mouse cancer cell lines (J774, LLC, and CT26) incubated for 24 hours with fullerenes and illuminated with white light. They found that some functionalized fullerenes (particularly monopyrrolidinium fullerene) induced apoptosis in all cancer lines (Free Radic. Biol. Med. 2007;43:711-9). In a subsequent study, Mroz et al. found that some fullerenes can be functionalized to photoinactivate pathogenic malignant cancer cells and/or microbial cells in a mechanism that involves superoxide anion and singlet oxygen. The researchers suggested that fullerenes have the potential to supersede photosensitizers in current clinical use in PDT for some conditions (Photochem. Photobiol. Sci. 2007;6:1139-49).

In 2009, Yin et al. showed that three different functionalized water-soluble fullerenes can intercept and protect cells against all of the primary physiologically important ROS and can efficiently suppress lipid peroxidation in vitro. The findings suggest the potential of fullerene derivatives as effective cytoprotective therapeutic agents (Biomaterials. 2009;30:611-21), the researchers wrote.

Conclusion

The discovery of the fullerene family has stimulated widespread research in chemistry and biology for a broad range of therapeutic applications. Anti-inflammatory, antioxidant, and antiviral activities have been linked to these compounds. In addition, fullerenes appear to be effective in drug and gene delivery and as an adjunct in acne therapy. The compounds have shown potential as photoprotectants as well as photosensitizers, which may be useful in photodynamic therapy. More research is needed, but the potential applications of fullerenes in dermatology are promising, particularly as potent antioxidants conferring skin protection.

Dr. Baumann is in private practice in Miami Beach. She did not disclose any conflicts of interest.

Courtesy Wikimedia Commons/Jynto/Creative Commons Licesnse

Discovered in nature in 1985 (Science 1992;257:215-7), fullerenes are novel, classically engineered chemical compounds composed only of carbon atoms. The stable form, a third carbon allotrope, is a molecule made up of 60 carbon atoms in a structure resembling a soccer ball or geodesic dome, although some fullerenes are ellipsoid or tube shaped. In fact, fullerene C(60), the first of the group of compounds to be discovered, is also known as buckminsterfullerene, based on Buckminster Fuller’s geodesic dome. The carbon nanotube structure, composed of thin carbon filaments (1-3 mcm in length and 1-3 nm in diameter) and possessing a wide range of mechanical characteristics, was discovered in 1991 (J. Nanosci. Nanotechnol. 2006;6:591-9).

The potential applications of C(60) and fullerene derivatives have been extensively studied, and recent data suggest that fullerenes exhibit potent antioxidant activity, even acting as a "free radical sponge" (Bioorg. Med. Chem. Lett. 2006;16:1590-5; Biomaterials 2008;29:3561-73). Therefore, fullerenes may be appropriate active ingredients for various skin care products, particularly rejuvenation products (Recent Pat. Biotechnol. 2011;5:67-73; Recent. Pat. Biotechnol. 2009;3:118-23).

Courtesy Wikimedia Commons/Jynto/Creative Commons Licesnse

Early studies

In one of the early studies of topical applications of fullerenes (C60), Nelson et al. examined the potential acute and subchronic toxic effects of fullerenes (200 mcg) applied in benzene on mouse skin. After 72 hours, they observed no effect on either DNA synthesis or ornithine decarboxylase activity. A skin tumor initiation model using 7,12-dimethylbenzanthracene (DMBA) failed to show benign or malignant skin tumor formation, but promotion using 12-O-tetradecanoyl-phorbol-13-acetate (TPA) resulted in benign skin tumors. The investigators concluded that fullerenes applied in benzene at a likely industrial exposure level did not cause acute toxic effects in mice (Toxicol. Ind. Health. 1993;9:623-30).

In 1997, Tabata et al., noted that fullerene C(60) efficiently generates singlet oxygen when irradiated with light, and found that polyethylene glycol (PEG)-modified C60 exhibits potential as an agent for photodynamic tumor therapy (Jpn. J. Cancer Res. 1997;88:1108-16).

Antiviral capacity

Fullerenes exhibit unique chemical and physical properties, including photodynamic characteristics and a hydrophobic spheroid and radical sponge quality. They also display antiviral activity, particularly in relation to HIV, and their potential commercial applications include use in patent-pending anticancer drug delivery systems employing photodynamic therapy (PDT), HIV drugs, and antiaging cosmetics (Int. J. Nanomedicine 2007;2:639-49).

Anti-inflammatory activity

An anti-inflammatory role has also been identified for fullerenes. Ryan et al. noted that preincubation with C(60) resulted in significant suppression of IgE-dependent mediator release in human mast cells and peripheral blood basophils. IgE-induced increases in cytoplasmic reactive oxygen species (ROS) levels was also hindered by preincubation with fullerenes. Using a mast cell–dependent anaphylaxis model, Ryan and colleagues also found that fullerenes prevented the in vivo release of histamine and fall in core body temperature. They concluded that fullerenes might suggest an innovative approach to managing mast cell–dependent conditions such as asthma, heart disease, inflammatory arthritis, and multiple sclerosis (J. Immunol. 2007;179(1):665-72).

Antimicrobial potential

In 2005, Tegos et al. compared the antimicrobial activity of six C(60) compounds functionalized with one, two, or three hydrophilic or cationic groups combined with white light against gram-positive and negative bacteria, and fungi. They found that following 10 minutes of incubation, bis- and tris-cationic fullerenes actively eliminated all tested microbes while leaving mammalian cells comparatively intact. The investigators also noted that the fullerene compounds were significantly more effective than a widely used antimicrobial photosensitizer, toluidine blue O. They concluded that the compounds warrant consideration as photosensitizers for antimicrobial use given their high selectivity and efficacy (Chem. Biol. 2005;12(10):1127-35).

Potent antioxidant

In 2006, Xiao et al. reported on their development of the Radical Sponge, a fullerene entrapped in polyvinylpyrrolidone to yield a water-soluble derivative with a mean particle diameter of about 688 nm and reactive oxygen species (ROS) scavenging abilities. The researchers repeatedly irradiated human skin keratinocytes (HaCaT) with visible light (400-2,000 nm) in the presence or absence of Radical Sponge, with no photocytotoxicity apparent in the Radical Sponge–exposed cells. In addition, the water-soluble fullerene derivative displayed a cytoprotective effect (10-40 mcM doses) against UVA exposure (30 J/cm²) when it was administered prior to exposure and rinsed out immediately before the irradiation, more so than when administered only during or after irradiation. The researchers concluded that this finding suggested more of a preventive as opposed to therapeutic effect conferred by Radical Sponge against UVA damage (Bioorg. Med. Chem. Lett. 2006;16:1590-5).

In a subsequent study, the researchers compared the Radical Sponge with two whitening agents and found the fullerene to have imparted stronger antimelanogenic activity, possibly due to down-regulation of the tyrosinase expression promoted by UVA-induced ROS generation (Arch. Dermatol. Res. 2007;299(5-6):245-57).

More recently, Kato et al. demonstrated the antioxidant activity of C(60) incorporated into liposomes, with persistent scavenging of hydroxyl radicals and cytoprotection of keratinocytes against UVA- and UVB-induced damage ascribed to the fullerene component (J. Nanosci. Nanotechnol. 2011;11(5):3814-23).

Safety

The first study establishing the safety of highly purified fullerenes (HPFs) as an additive in cosmeceuticals was conducted in 2009. Aoshima et al. performed in vivo tests in animals and in vitro examinations using human epidermal keratinocytes and fibroblasts. No primary or cumulative skin irritation, sensitization, photosensitization, or contact phototoxicity was observed. In the patch test on human skin, no reaction was noted. HPFs were deemed to be "minimally irritating" after the eye-irritation test in rabbits. The investigators concluded, based on their findings and in light of previously published data, that HPFs are safe for human skin as ingredients in cosmetic skin care formulations (J. Toxicol. Sci. 2009;34(5):555-62).

Hair regrowth

In 2009, Zhou et al. used shaved mice and SKH-1 hairless mice to study whether fullerene-based compounds could elicit hair growth. Fullerenes were found to significantly increase the hair growth rate compared with a placebo vehicle. Significantly increased numbers of hair follicles were also observed in SKH-1 hairless mice treated topically or subdermally with fullerenes. Cultured human skin treated with fullerenes also showed augmented hair growth. The data suggested implications for hair loss due to alopecia, chemotherapy, or other chemical reactions (Nanomedicine 2009;5:202-7).

Antiacne properties

In 2011, Inui et al. conducted an open trial of effects of fullerene gel on acne. Subjects used the gel twice daily, and significant reductions in the mean number of inflammatory lesions were noted at 4 and 8 weeks of treatment. In addition, the researchers conducted in vitro assays of sebum production in hamster sebocytes and found that 75 mcM polyvinylpyrrolidone-fullerene suppressed sebum production, suggesting that topical fullerenes inhibit acne by reducing neutrophil infiltration and sebum production (Nanomedicine 2011;7:238-41).

Water solubility and photodynamic activity

In 2007, Mroz et al. compared the photodynamic activity of six fullerenes functionalized to become soluble with 1, 2, or 3 hydrophilic or 1, 2, or 3 cationic groups in three mouse cancer cell lines (J774, LLC, and CT26) incubated for 24 hours with fullerenes and illuminated with white light. They found that some functionalized fullerenes (particularly monopyrrolidinium fullerene) induced apoptosis in all cancer lines (Free Radic. Biol. Med. 2007;43:711-9). In a subsequent study, Mroz et al. found that some fullerenes can be functionalized to photoinactivate pathogenic malignant cancer cells and/or microbial cells in a mechanism that involves superoxide anion and singlet oxygen. The researchers suggested that fullerenes have the potential to supersede photosensitizers in current clinical use in PDT for some conditions (Photochem. Photobiol. Sci. 2007;6:1139-49).

In 2009, Yin et al. showed that three different functionalized water-soluble fullerenes can intercept and protect cells against all of the primary physiologically important ROS and can efficiently suppress lipid peroxidation in vitro. The findings suggest the potential of fullerene derivatives as effective cytoprotective therapeutic agents (Biomaterials. 2009;30:611-21), the researchers wrote.

Conclusion

The discovery of the fullerene family has stimulated widespread research in chemistry and biology for a broad range of therapeutic applications. Anti-inflammatory, antioxidant, and antiviral activities have been linked to these compounds. In addition, fullerenes appear to be effective in drug and gene delivery and as an adjunct in acne therapy. The compounds have shown potential as photoprotectants as well as photosensitizers, which may be useful in photodynamic therapy. More research is needed, but the potential applications of fullerenes in dermatology are promising, particularly as potent antioxidants conferring skin protection.

Dr. Baumann is in private practice in Miami Beach. She did not disclose any conflicts of interest.

Courtesy Wikimedia Commons/Jynto/Creative Commons Licesnse

MIAMI BEACH – ATX-101, an investigational injectable deoxycholic acid, is safe and effective for the non-surgical reduction of submental fat, according to interim findings from a 12-month phase IIIb open-label study.

At 3-month follow-up after their last treatment, 87% and 83% of 165 study participants achieved at least a 1-point improvement on the clinician and patient submental fat rating scales, respectively, Dr. Susan Weinkle reported during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

"That is major," Dr. Weinkle, a dermatologist in private practice in Bradenton, Fla., said of the patients’ rating scale scores.

Patients reported feeling less bothered by, and self-conscious about, their submental fat, and they also reported feeling younger. Most – about 96% – experienced unchanged or improved skin laxity in the treated area.

"Many, despite the fact that their body mass index stayed the same, actually felt like they looked like they had lost weight ... let me tell you, they were very, very happy," she said.

In fact, 94% reported being happy they had the procedure.

The study participants were men and women of varying ages, races, and Fitzpatrick skin types, who were dissatisfied with their appearance associated with the chin region. All had submental fat scale scores of 2 to 4 on both clinician and patient rating scales, had stable weight, and had received no prior treatments to the submental fat region. They received up to 6 treatments, at 4-week intervals, with ATX-101 at a dosage of 2 mg/cm². Injections were administered with a 30-gauge needle, and "little microinjections at 2 mm areas across the submental region," Dr. Weinkle said, noting that the number of injections was tailored as the fat decreased over time.

Treatments were provided at 21 sites across the United States.

Treatment-related adverse events occurred in more than 91% of patients, but these were mainly mild-to-moderate injection site hematomas, numbness, pain, edema, and erythema – and all were transient, she said

No changes in blood lipids occurred.

This "really exciting research" suggests that ATX-101, a synthetically derived product that has been shown to destroy and eliminate fat through adipocytolysis, "may very well provide, in the future, an approach to submental fat for our patients who are so unhappy with this part of their body," she said.

"This is an important thing to people, and it makes a huge difference ... if [ATX-101] has the opportunity to come to market, it will make a big impact for our patients," she added.

To date, between 2,000 and 3,000 patients have been studied, including 1,500 who have received active treatment, and 1,500 who received placebo. Patients in the current study will be followed out to 12 months, she said.

This study was funded by Kythera. Dr. Weinkle disclosed that she worked with Kythera as an investigator for the study.

MIAMI BEACH – ATX-101, an investigational injectable deoxycholic acid, is safe and effective for the non-surgical reduction of submental fat, according to interim findings from a 12-month phase IIIb open-label study.

At 3-month follow-up after their last treatment, 87% and 83% of 165 study participants achieved at least a 1-point improvement on the clinician and patient submental fat rating scales, respectively, Dr. Susan Weinkle reported during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

"That is major," Dr. Weinkle, a dermatologist in private practice in Bradenton, Fla., said of the patients’ rating scale scores.

Patients reported feeling less bothered by, and self-conscious about, their submental fat, and they also reported feeling younger. Most – about 96% – experienced unchanged or improved skin laxity in the treated area.

"Many, despite the fact that their body mass index stayed the same, actually felt like they looked like they had lost weight ... let me tell you, they were very, very happy," she said.

In fact, 94% reported being happy they had the procedure.

The study participants were men and women of varying ages, races, and Fitzpatrick skin types, who were dissatisfied with their appearance associated with the chin region. All had submental fat scale scores of 2 to 4 on both clinician and patient rating scales, had stable weight, and had received no prior treatments to the submental fat region. They received up to 6 treatments, at 4-week intervals, with ATX-101 at a dosage of 2 mg/cm². Injections were administered with a 30-gauge needle, and "little microinjections at 2 mm areas across the submental region," Dr. Weinkle said, noting that the number of injections was tailored as the fat decreased over time.

Treatments were provided at 21 sites across the United States.

Treatment-related adverse events occurred in more than 91% of patients, but these were mainly mild-to-moderate injection site hematomas, numbness, pain, edema, and erythema – and all were transient, she said

No changes in blood lipids occurred.

This "really exciting research" suggests that ATX-101, a synthetically derived product that has been shown to destroy and eliminate fat through adipocytolysis, "may very well provide, in the future, an approach to submental fat for our patients who are so unhappy with this part of their body," she said.

"This is an important thing to people, and it makes a huge difference ... if [ATX-101] has the opportunity to come to market, it will make a big impact for our patients," she added.

To date, between 2,000 and 3,000 patients have been studied, including 1,500 who have received active treatment, and 1,500 who received placebo. Patients in the current study will be followed out to 12 months, she said.

This study was funded by Kythera. Dr. Weinkle disclosed that she worked with Kythera as an investigator for the study.

MIAMI BEACH – ATX-101, an investigational injectable deoxycholic acid, is safe and effective for the non-surgical reduction of submental fat, according to interim findings from a 12-month phase IIIb open-label study.

At 3-month follow-up after their last treatment, 87% and 83% of 165 study participants achieved at least a 1-point improvement on the clinician and patient submental fat rating scales, respectively, Dr. Susan Weinkle reported during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

"That is major," Dr. Weinkle, a dermatologist in private practice in Bradenton, Fla., said of the patients’ rating scale scores.

Patients reported feeling less bothered by, and self-conscious about, their submental fat, and they also reported feeling younger. Most – about 96% – experienced unchanged or improved skin laxity in the treated area.

"Many, despite the fact that their body mass index stayed the same, actually felt like they looked like they had lost weight ... let me tell you, they were very, very happy," she said.

In fact, 94% reported being happy they had the procedure.

The study participants were men and women of varying ages, races, and Fitzpatrick skin types, who were dissatisfied with their appearance associated with the chin region. All had submental fat scale scores of 2 to 4 on both clinician and patient rating scales, had stable weight, and had received no prior treatments to the submental fat region. They received up to 6 treatments, at 4-week intervals, with ATX-101 at a dosage of 2 mg/cm². Injections were administered with a 30-gauge needle, and "little microinjections at 2 mm areas across the submental region," Dr. Weinkle said, noting that the number of injections was tailored as the fat decreased over time.

Treatments were provided at 21 sites across the United States.

Treatment-related adverse events occurred in more than 91% of patients, but these were mainly mild-to-moderate injection site hematomas, numbness, pain, edema, and erythema – and all were transient, she said

No changes in blood lipids occurred.

This "really exciting research" suggests that ATX-101, a synthetically derived product that has been shown to destroy and eliminate fat through adipocytolysis, "may very well provide, in the future, an approach to submental fat for our patients who are so unhappy with this part of their body," she said.

"This is an important thing to people, and it makes a huge difference ... if [ATX-101] has the opportunity to come to market, it will make a big impact for our patients," she added.

To date, between 2,000 and 3,000 patients have been studied, including 1,500 who have received active treatment, and 1,500 who received placebo. Patients in the current study will be followed out to 12 months, she said.

This study was funded by Kythera. Dr. Weinkle disclosed that she worked with Kythera as an investigator for the study.

Carolyn Jacob, MD

Hyperhidrosis is the production of sweat above and beyond normal physiological needs, regardless of the ambient temperature, and it affects >4% of the population. In addition, a poll showed up to 21% of the population is bothered on a daily basis by their amount of underarm sweating. Despite the large number of patients who suffer from hyperhidrosis, there are relatively few effective nonsurgical treatment options. A new, nonsurgical, lasting treatment for axillary hyperhidrosis has now been developed using microwave technology to eliminate sweat glands.

*For a PDF of the full article, click on the link to the left of this introduction.

Carolyn Jacob, MD

Hyperhidrosis is the production of sweat above and beyond normal physiological needs, regardless of the ambient temperature, and it affects >4% of the population. In addition, a poll showed up to 21% of the population is bothered on a daily basis by their amount of underarm sweating. Despite the large number of patients who suffer from hyperhidrosis, there are relatively few effective nonsurgical treatment options. A new, nonsurgical, lasting treatment for axillary hyperhidrosis has now been developed using microwave technology to eliminate sweat glands.

*For a PDF of the full article, click on the link to the left of this introduction.

Carolyn Jacob, MD

Hyperhidrosis is the production of sweat above and beyond normal physiological needs, regardless of the ambient temperature, and it affects >4% of the population. In addition, a poll showed up to 21% of the population is bothered on a daily basis by their amount of underarm sweating. Despite the large number of patients who suffer from hyperhidrosis, there are relatively few effective nonsurgical treatment options. A new, nonsurgical, lasting treatment for axillary hyperhidrosis has now been developed using microwave technology to eliminate sweat glands.

*For a PDF of the full article, click on the link to the left of this introduction.

Robert A. Weiss, MD, FAAD, FACPh

The medical use of radio frequency (RF) is based on an oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. RF heating occurs irrespective of chromophore or skin type and is not dependent on selective photothermolysis. RF can be delivered using monopolar, bipolar, and unipolar devices, and each method has theoretical limits of depth penetration. A variant of bipolar delivery is fractional RF delivery. In monopolar configurations, RF will penetrate deeply and return via a grounding electrode. Multiple devices are available and are detailed later in the text. RF thermal stimulation is believed to result in a microinflammatory process that promotes new collagen. By manipulating skin cooling, RF can also be used for heating and reduction of fat. Currently, the most common uses of RF-based devices are to noninvasively manage and treat skin tightening of lax skin (including sagging jowls, abdomen, thighs, and arms), as well as wrinkle reduction, cellulite improvement, and body contouring.

*For a PDF of the full article, click on the link to the left of this introduction.

Robert A. Weiss, MD, FAAD, FACPh

The medical use of radio frequency (RF) is based on an oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. RF heating occurs irrespective of chromophore or skin type and is not dependent on selective photothermolysis. RF can be delivered using monopolar, bipolar, and unipolar devices, and each method has theoretical limits of depth penetration. A variant of bipolar delivery is fractional RF delivery. In monopolar configurations, RF will penetrate deeply and return via a grounding electrode. Multiple devices are available and are detailed later in the text. RF thermal stimulation is believed to result in a microinflammatory process that promotes new collagen. By manipulating skin cooling, RF can also be used for heating and reduction of fat. Currently, the most common uses of RF-based devices are to noninvasively manage and treat skin tightening of lax skin (including sagging jowls, abdomen, thighs, and arms), as well as wrinkle reduction, cellulite improvement, and body contouring.

*For a PDF of the full article, click on the link to the left of this introduction.

Robert A. Weiss, MD, FAAD, FACPh

The medical use of radio frequency (RF) is based on an oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. RF heating occurs irrespective of chromophore or skin type and is not dependent on selective photothermolysis. RF can be delivered using monopolar, bipolar, and unipolar devices, and each method has theoretical limits of depth penetration. A variant of bipolar delivery is fractional RF delivery. In monopolar configurations, RF will penetrate deeply and return via a grounding electrode. Multiple devices are available and are detailed later in the text. RF thermal stimulation is believed to result in a microinflammatory process that promotes new collagen. By manipulating skin cooling, RF can also be used for heating and reduction of fat. Currently, the most common uses of RF-based devices are to noninvasively manage and treat skin tightening of lax skin (including sagging jowls, abdomen, thighs, and arms), as well as wrinkle reduction, cellulite improvement, and body contouring.

*For a PDF of the full article, click on the link to the left of this introduction.

Jennifer L. MacGregor, MD, and Elizabeth L. Tanzi, MD

The demand for noninvasive skin tightening procedures is increasing as patients seek safe and effective alternatives to aesthetic surgical procedures of the face, neck, and body. Over the past decade, radiofrequency and infrared laser devices have been popularized owing to their ability to deliver controlled heat to the dermis, stimulate neocollagenesis, and effect modest tissue tightening with minimal recovery. However, these less invasive approaches are historically associated with inferior efficacy so that surgery still remains the treatment of choice to address moderate to severe tissue laxity. Microfocused ultrasound was recently introduced as a novel energy modality for transcutaneous heat delivery that reaches the deeper subdermal connective tissue in tightly focused zones at consistent programmed depths. The goal is to produce a deeper wound healing response at multiple levels with robust collagen remodeling and a more durable clinical response. The Ulthera device (Ulthera, Inc, Meza, AZ), with refined microfocused ultrasound technology, has been adapted specifically for skin tightening and lifting with little recovery or risk of complications since its introduction in 2009. As clinical parameters are studied and optimized, enhanced efficacy and consistency of clinical improvement is expected.

*For a PDF of the full article, click on the link to the left of this introduction.

Jennifer L. MacGregor, MD, and Elizabeth L. Tanzi, MD

The demand for noninvasive skin tightening procedures is increasing as patients seek safe and effective alternatives to aesthetic surgical procedures of the face, neck, and body. Over the past decade, radiofrequency and infrared laser devices have been popularized owing to their ability to deliver controlled heat to the dermis, stimulate neocollagenesis, and effect modest tissue tightening with minimal recovery. However, these less invasive approaches are historically associated with inferior efficacy so that surgery still remains the treatment of choice to address moderate to severe tissue laxity. Microfocused ultrasound was recently introduced as a novel energy modality for transcutaneous heat delivery that reaches the deeper subdermal connective tissue in tightly focused zones at consistent programmed depths. The goal is to produce a deeper wound healing response at multiple levels with robust collagen remodeling and a more durable clinical response. The Ulthera device (Ulthera, Inc, Meza, AZ), with refined microfocused ultrasound technology, has been adapted specifically for skin tightening and lifting with little recovery or risk of complications since its introduction in 2009. As clinical parameters are studied and optimized, enhanced efficacy and consistency of clinical improvement is expected.

*For a PDF of the full article, click on the link to the left of this introduction.

Jennifer L. MacGregor, MD, and Elizabeth L. Tanzi, MD

The demand for noninvasive skin tightening procedures is increasing as patients seek safe and effective alternatives to aesthetic surgical procedures of the face, neck, and body. Over the past decade, radiofrequency and infrared laser devices have been popularized owing to their ability to deliver controlled heat to the dermis, stimulate neocollagenesis, and effect modest tissue tightening with minimal recovery. However, these less invasive approaches are historically associated with inferior efficacy so that surgery still remains the treatment of choice to address moderate to severe tissue laxity. Microfocused ultrasound was recently introduced as a novel energy modality for transcutaneous heat delivery that reaches the deeper subdermal connective tissue in tightly focused zones at consistent programmed depths. The goal is to produce a deeper wound healing response at multiple levels with robust collagen remodeling and a more durable clinical response. The Ulthera device (Ulthera, Inc, Meza, AZ), with refined microfocused ultrasound technology, has been adapted specifically for skin tightening and lifting with little recovery or risk of complications since its introduction in 2009. As clinical parameters are studied and optimized, enhanced efficacy and consistency of clinical improvement is expected.

*For a PDF of the full article, click on the link to the left of this introduction.