Aesthetic Dermatology

If you would like to learn more about issues in skin of color, and be part of an organization dedicated to promoting awareness and excellence in dermatology, please attend the Skin of Color Society's scientific symposium at the American Academy of Dermatology's annual meeting in Miami this Thursday, March 4, at 2 pm in the Loews Miami Beach Hotel (Ponciana 4 Room).

We hope to see you there!

Lily & Naissan

If you would like to learn more about issues in skin of color, and be part of an organization dedicated to promoting awareness and excellence in dermatology, please attend the Skin of Color Society's scientific symposium at the American Academy of Dermatology's annual meeting in Miami this Thursday, March 4, at 2 pm in the Loews Miami Beach Hotel (Ponciana 4 Room).

We hope to see you there!

Lily & Naissan

If you would like to learn more about issues in skin of color, and be part of an organization dedicated to promoting awareness and excellence in dermatology, please attend the Skin of Color Society's scientific symposium at the American Academy of Dermatology's annual meeting in Miami this Thursday, March 4, at 2 pm in the Loews Miami Beach Hotel (Ponciana 4 Room).

We hope to see you there!

Lily & Naissan

Cosmeceuticals - substances that exert both cosmetic and therapeutic benefits - will be a $16 billion business in 2010, according to Dr. Michael H. Gold.

While consumers can purchase hundreds of cosmeceutical products over the counter, many have never been subject to safety and efficacy testing, he said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

As a result, dermatologists have an important role to play in advising their patients, said Dr. Gold, of Vanderbilt University, Nashville. More and more, reputable cosmeceutical companies are subjecting their products to independent testing, with the results appearing in peer-reviewed scientific literature.

Antioxidants are the most commonly used active ingredients in most cosmeceuticals. "We're doing anything we can to use natural-based ingredients, plant derivatives, fruits, and vegetables, to reverse free-radical damage and to prevent skin aging," he said in an interview. "But I think we need to understand that not every fruit, vegetable, and plant has got something in it that's good for your skin."

The list of proven antioxidants is long, but it is important to remember that while antioxidants can slow the progression of wrinkles and other signs of skin aging, they cannot reverse the progression alone.

There is one exception, according to Dr. Gold. While Vitamin C is an antioxidant with the proven ability to prevent aging and ultraviolet-induced skin damage, it has another property. Through a separate mechanism, topically applied vitamin C induces collagen formation, and, thus, can be used to treat wrinkles.

Many other products claim to improve wrinkles, but this ability is almost always due to swelling or hydrating effects. Wrinkles return in full force once the product has worn off.

Because of its unique properties, vitamin C is a component of many cosmeceuticals, but it is important to consider how each product is packaged before recommending it, he said. Vitamin C, like many other antioxidants, is quite unstable, and can easily become oxidized and inactivated long before reaching the skin.

Vitamin C is rapidly inactivated by light or UV radiation. If the product is not in a dark container, the Vitamin C will quickly degrade.

Dr. Gold also noted that many antioxidants work synergistically. Cosmeceuticals that include more than one active ingredient are likely to be better than those based on a single antioxidant.

He is particularly interested in a line of cosmeceuticals manufactured by Neocutis. (Dr. Gold acknowledged serving as a consultant to that company, and his clinic sells their products.) In addition to antioxidants, many Neocutis products are based on growth factors that have shown synergy in improving skin.

Dr. Gold has conducted studies for the Neocutis product, Bio-restorative Skin Cream. One such study found the product to be effective in treating adverse events associated with photodynamic therapy (J. Drugs Dermatol. 2006;5:796-8). Another study demonstrated that the product is effective for facial skin rejuvenation as assessed by 3D in vivo optical skin imaging (J. Drugs Dermatol. 2007;6:1018-23). And a third study, presented at the annual meeting of the American Academy of Dermatology in 2006, showed that the product was effective in treating facial elastosis.

Although the Food and Drug Administration does not regulate cosmeceuticals, and they can be sold freely over the counter, Neocutis makes its products available only through physicians. Other companies do the same, and these products tend to be stronger and more efficacious than those sold in a local pharmacy.

Dr. Gold reserved particular scorn for cosmeceuticals that are sold through multilevel marketing schemes. "There are products out there that are snake oils," he said. "If you purchase anything in a pyramid scheme or a multilevel marketing company, you're just throwing good money away. We try to buy products from reputable companies, products that have had skin testing and appropriate clinical work done on them."

^{Photo Courtesy Dr. Michael H. Gold}

Dr. Gold also disclosed being a consultant for Obagi Medical and Steifel, and being a consultant, researcher, and speaker for numerous other pharmaceutical and medical device companies.

SDEF and this news organization are owned by Elsevier.

Cosmeceuticals - substances that exert both cosmetic and therapeutic benefits - will be a $16 billion business in 2010, according to Dr. Michael H. Gold.

While consumers can purchase hundreds of cosmeceutical products over the counter, many have never been subject to safety and efficacy testing, he said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

As a result, dermatologists have an important role to play in advising their patients, said Dr. Gold, of Vanderbilt University, Nashville. More and more, reputable cosmeceutical companies are subjecting their products to independent testing, with the results appearing in peer-reviewed scientific literature.

Antioxidants are the most commonly used active ingredients in most cosmeceuticals. "We're doing anything we can to use natural-based ingredients, plant derivatives, fruits, and vegetables, to reverse free-radical damage and to prevent skin aging," he said in an interview. "But I think we need to understand that not every fruit, vegetable, and plant has got something in it that's good for your skin."

The list of proven antioxidants is long, but it is important to remember that while antioxidants can slow the progression of wrinkles and other signs of skin aging, they cannot reverse the progression alone.

There is one exception, according to Dr. Gold. While Vitamin C is an antioxidant with the proven ability to prevent aging and ultraviolet-induced skin damage, it has another property. Through a separate mechanism, topically applied vitamin C induces collagen formation, and, thus, can be used to treat wrinkles.

Many other products claim to improve wrinkles, but this ability is almost always due to swelling or hydrating effects. Wrinkles return in full force once the product has worn off.

Because of its unique properties, vitamin C is a component of many cosmeceuticals, but it is important to consider how each product is packaged before recommending it, he said. Vitamin C, like many other antioxidants, is quite unstable, and can easily become oxidized and inactivated long before reaching the skin.

Vitamin C is rapidly inactivated by light or UV radiation. If the product is not in a dark container, the Vitamin C will quickly degrade.

Dr. Gold also noted that many antioxidants work synergistically. Cosmeceuticals that include more than one active ingredient are likely to be better than those based on a single antioxidant.

He is particularly interested in a line of cosmeceuticals manufactured by Neocutis. (Dr. Gold acknowledged serving as a consultant to that company, and his clinic sells their products.) In addition to antioxidants, many Neocutis products are based on growth factors that have shown synergy in improving skin.

Dr. Gold has conducted studies for the Neocutis product, Bio-restorative Skin Cream. One such study found the product to be effective in treating adverse events associated with photodynamic therapy (J. Drugs Dermatol. 2006;5:796-8). Another study demonstrated that the product is effective for facial skin rejuvenation as assessed by 3D in vivo optical skin imaging (J. Drugs Dermatol. 2007;6:1018-23). And a third study, presented at the annual meeting of the American Academy of Dermatology in 2006, showed that the product was effective in treating facial elastosis.

Although the Food and Drug Administration does not regulate cosmeceuticals, and they can be sold freely over the counter, Neocutis makes its products available only through physicians. Other companies do the same, and these products tend to be stronger and more efficacious than those sold in a local pharmacy.

Dr. Gold reserved particular scorn for cosmeceuticals that are sold through multilevel marketing schemes. "There are products out there that are snake oils," he said. "If you purchase anything in a pyramid scheme or a multilevel marketing company, you're just throwing good money away. We try to buy products from reputable companies, products that have had skin testing and appropriate clinical work done on them."

^{Photo Courtesy Dr. Michael H. Gold}

Dr. Gold also disclosed being a consultant for Obagi Medical and Steifel, and being a consultant, researcher, and speaker for numerous other pharmaceutical and medical device companies.

SDEF and this news organization are owned by Elsevier.

Cosmeceuticals - substances that exert both cosmetic and therapeutic benefits - will be a $16 billion business in 2010, according to Dr. Michael H. Gold.

While consumers can purchase hundreds of cosmeceutical products over the counter, many have never been subject to safety and efficacy testing, he said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

As a result, dermatologists have an important role to play in advising their patients, said Dr. Gold, of Vanderbilt University, Nashville. More and more, reputable cosmeceutical companies are subjecting their products to independent testing, with the results appearing in peer-reviewed scientific literature.

Antioxidants are the most commonly used active ingredients in most cosmeceuticals. "We're doing anything we can to use natural-based ingredients, plant derivatives, fruits, and vegetables, to reverse free-radical damage and to prevent skin aging," he said in an interview. "But I think we need to understand that not every fruit, vegetable, and plant has got something in it that's good for your skin."

The list of proven antioxidants is long, but it is important to remember that while antioxidants can slow the progression of wrinkles and other signs of skin aging, they cannot reverse the progression alone.

There is one exception, according to Dr. Gold. While Vitamin C is an antioxidant with the proven ability to prevent aging and ultraviolet-induced skin damage, it has another property. Through a separate mechanism, topically applied vitamin C induces collagen formation, and, thus, can be used to treat wrinkles.

Many other products claim to improve wrinkles, but this ability is almost always due to swelling or hydrating effects. Wrinkles return in full force once the product has worn off.

Because of its unique properties, vitamin C is a component of many cosmeceuticals, but it is important to consider how each product is packaged before recommending it, he said. Vitamin C, like many other antioxidants, is quite unstable, and can easily become oxidized and inactivated long before reaching the skin.

Vitamin C is rapidly inactivated by light or UV radiation. If the product is not in a dark container, the Vitamin C will quickly degrade.

Dr. Gold also noted that many antioxidants work synergistically. Cosmeceuticals that include more than one active ingredient are likely to be better than those based on a single antioxidant.

He is particularly interested in a line of cosmeceuticals manufactured by Neocutis. (Dr. Gold acknowledged serving as a consultant to that company, and his clinic sells their products.) In addition to antioxidants, many Neocutis products are based on growth factors that have shown synergy in improving skin.

Dr. Gold has conducted studies for the Neocutis product, Bio-restorative Skin Cream. One such study found the product to be effective in treating adverse events associated with photodynamic therapy (J. Drugs Dermatol. 2006;5:796-8). Another study demonstrated that the product is effective for facial skin rejuvenation as assessed by 3D in vivo optical skin imaging (J. Drugs Dermatol. 2007;6:1018-23). And a third study, presented at the annual meeting of the American Academy of Dermatology in 2006, showed that the product was effective in treating facial elastosis.

Although the Food and Drug Administration does not regulate cosmeceuticals, and they can be sold freely over the counter, Neocutis makes its products available only through physicians. Other companies do the same, and these products tend to be stronger and more efficacious than those sold in a local pharmacy.

Dr. Gold reserved particular scorn for cosmeceuticals that are sold through multilevel marketing schemes. "There are products out there that are snake oils," he said. "If you purchase anything in a pyramid scheme or a multilevel marketing company, you're just throwing good money away. We try to buy products from reputable companies, products that have had skin testing and appropriate clinical work done on them."

^{Photo Courtesy Dr. Michael H. Gold}

Dr. Gold also disclosed being a consultant for Obagi Medical and Steifel, and being a consultant, researcher, and speaker for numerous other pharmaceutical and medical device companies.

SDEF and this news organization are owned by Elsevier.

Now that more than one injectable formulation of botulinum toxin is on the market, the competition may help drive down prices. 

Aside from potential price differences, little seems to distinguish the two injectable formulations of botulinum toxin type A on the market, Botox (Allergan) and Dysport (Medicis), Dr. Mark G. Rubin explained at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

"As of January 2010, I have injected over 700 patients with Dysport, all of whom have had Botox previously. In the vast majority of patients, they were unable to tell the difference," said Dr. Rubin, a dermatologist in private practice in Beverly Hills, Calif.

Price competition among various botulinum toxin type A brands will likely intensify when additional formulations, PurTox (Mentor) and Xeomin (Merz), receive expected Food and Drug Administration approvals.

These brands differ by parameters that include complexing proteins, dose equivalency, and need for refrigeration, but available data suggest few meaningful differences exist except for storage temperature. Both Botox and Dysport require refrigerated storage, while Xeomin and PurTox are stable when stored at temperatures up to 25º C, Dr. Rubin noted.

Perhaps the most hyped difference among botulinum toxin type A formulations is spread or diffusion following injection, a property also known as "field of effect." The evidence indicates little difference in the diffusion rates of Botox and Dysport, according to Dr. Rubin.

The active molecule in botulinum toxin type A is identical in all formulations. The difference is the complexing proteins that wrap around the active molecule. Data reported at the Toxins 2008 meeting in Baveno, Italy showed that, at physiological pH, the active molecule dissociates from complexing protein within 1 minute, after which diffusion should be the same for all formulations.

This interpretation received further support from data that showed the onset of action, efficacy, and duration of effect of Botox and Xeomin were nearly identical (Neurology 2005;64:1949-51; J. Neural Transm. 2006;113:303-12).

Additional results from other studies have also supported the notion that Botox, Dysport, and Xeomin all act in similar ways, he noted. Moreover, trials done for the FDA for treatment of blepharospasm and cervical dystonia showed similar adverse effect profiles for Botox and Xeomin, suggesting similar diffusion rates.

The only other area in which some of these products differ is in dosing. Xeomin and PurTox appear roughly similar in dosing to Botox, with 1 unit of each being about equivalent to 1 unit of Botox. Dysport, though, has different dosing: 2.5 units of Dysport generally have the same effect as 1 unit of Botox.

Dysport and Botox also have shown similar efficacy and adverse effect profiles in clinical studies, according to Dr. Rubin. In effects on frown lines, Botox has been found to have 84% efficacy, compared with 90% for Dysport. Median duration of response has been found to be 90 days for Botox and 117 days for Dysport. The incidence of headaches is reported to be 15% with Botox and 11% with Dysport, and the rate of blepharoptosis is 5% with Botox and less than 2% with Dysport, he reported.

^{Photo Courtesy Dr. Mark G. Rubin}

Dr. Rubin disclosed being a consultant to Medicis, the company that markets Dysport, and to Revance Therapeutics, a company developing a topical formulation of botulinum toxin. SDEF and this news organization are owned by Elsevier.

Now that more than one injectable formulation of botulinum toxin is on the market, the competition may help drive down prices. 

Aside from potential price differences, little seems to distinguish the two injectable formulations of botulinum toxin type A on the market, Botox (Allergan) and Dysport (Medicis), Dr. Mark G. Rubin explained at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

"As of January 2010, I have injected over 700 patients with Dysport, all of whom have had Botox previously. In the vast majority of patients, they were unable to tell the difference," said Dr. Rubin, a dermatologist in private practice in Beverly Hills, Calif.

Price competition among various botulinum toxin type A brands will likely intensify when additional formulations, PurTox (Mentor) and Xeomin (Merz), receive expected Food and Drug Administration approvals.

These brands differ by parameters that include complexing proteins, dose equivalency, and need for refrigeration, but available data suggest few meaningful differences exist except for storage temperature. Both Botox and Dysport require refrigerated storage, while Xeomin and PurTox are stable when stored at temperatures up to 25º C, Dr. Rubin noted.

Perhaps the most hyped difference among botulinum toxin type A formulations is spread or diffusion following injection, a property also known as "field of effect." The evidence indicates little difference in the diffusion rates of Botox and Dysport, according to Dr. Rubin.

The active molecule in botulinum toxin type A is identical in all formulations. The difference is the complexing proteins that wrap around the active molecule. Data reported at the Toxins 2008 meeting in Baveno, Italy showed that, at physiological pH, the active molecule dissociates from complexing protein within 1 minute, after which diffusion should be the same for all formulations.

This interpretation received further support from data that showed the onset of action, efficacy, and duration of effect of Botox and Xeomin were nearly identical (Neurology 2005;64:1949-51; J. Neural Transm. 2006;113:303-12).

Additional results from other studies have also supported the notion that Botox, Dysport, and Xeomin all act in similar ways, he noted. Moreover, trials done for the FDA for treatment of blepharospasm and cervical dystonia showed similar adverse effect profiles for Botox and Xeomin, suggesting similar diffusion rates.

The only other area in which some of these products differ is in dosing. Xeomin and PurTox appear roughly similar in dosing to Botox, with 1 unit of each being about equivalent to 1 unit of Botox. Dysport, though, has different dosing: 2.5 units of Dysport generally have the same effect as 1 unit of Botox.

Dysport and Botox also have shown similar efficacy and adverse effect profiles in clinical studies, according to Dr. Rubin. In effects on frown lines, Botox has been found to have 84% efficacy, compared with 90% for Dysport. Median duration of response has been found to be 90 days for Botox and 117 days for Dysport. The incidence of headaches is reported to be 15% with Botox and 11% with Dysport, and the rate of blepharoptosis is 5% with Botox and less than 2% with Dysport, he reported.

^{Photo Courtesy Dr. Mark G. Rubin}

Dr. Rubin disclosed being a consultant to Medicis, the company that markets Dysport, and to Revance Therapeutics, a company developing a topical formulation of botulinum toxin. SDEF and this news organization are owned by Elsevier.

Now that more than one injectable formulation of botulinum toxin is on the market, the competition may help drive down prices. 

Aside from potential price differences, little seems to distinguish the two injectable formulations of botulinum toxin type A on the market, Botox (Allergan) and Dysport (Medicis), Dr. Mark G. Rubin explained at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

"As of January 2010, I have injected over 700 patients with Dysport, all of whom have had Botox previously. In the vast majority of patients, they were unable to tell the difference," said Dr. Rubin, a dermatologist in private practice in Beverly Hills, Calif.

Price competition among various botulinum toxin type A brands will likely intensify when additional formulations, PurTox (Mentor) and Xeomin (Merz), receive expected Food and Drug Administration approvals.

These brands differ by parameters that include complexing proteins, dose equivalency, and need for refrigeration, but available data suggest few meaningful differences exist except for storage temperature. Both Botox and Dysport require refrigerated storage, while Xeomin and PurTox are stable when stored at temperatures up to 25º C, Dr. Rubin noted.

Perhaps the most hyped difference among botulinum toxin type A formulations is spread or diffusion following injection, a property also known as "field of effect." The evidence indicates little difference in the diffusion rates of Botox and Dysport, according to Dr. Rubin.

The active molecule in botulinum toxin type A is identical in all formulations. The difference is the complexing proteins that wrap around the active molecule. Data reported at the Toxins 2008 meeting in Baveno, Italy showed that, at physiological pH, the active molecule dissociates from complexing protein within 1 minute, after which diffusion should be the same for all formulations.

This interpretation received further support from data that showed the onset of action, efficacy, and duration of effect of Botox and Xeomin were nearly identical (Neurology 2005;64:1949-51; J. Neural Transm. 2006;113:303-12).

Additional results from other studies have also supported the notion that Botox, Dysport, and Xeomin all act in similar ways, he noted. Moreover, trials done for the FDA for treatment of blepharospasm and cervical dystonia showed similar adverse effect profiles for Botox and Xeomin, suggesting similar diffusion rates.

The only other area in which some of these products differ is in dosing. Xeomin and PurTox appear roughly similar in dosing to Botox, with 1 unit of each being about equivalent to 1 unit of Botox. Dysport, though, has different dosing: 2.5 units of Dysport generally have the same effect as 1 unit of Botox.

Dysport and Botox also have shown similar efficacy and adverse effect profiles in clinical studies, according to Dr. Rubin. In effects on frown lines, Botox has been found to have 84% efficacy, compared with 90% for Dysport. Median duration of response has been found to be 90 days for Botox and 117 days for Dysport. The incidence of headaches is reported to be 15% with Botox and 11% with Dysport, and the rate of blepharoptosis is 5% with Botox and less than 2% with Dysport, he reported.

^{Photo Courtesy Dr. Mark G. Rubin}

Dr. Rubin disclosed being a consultant to Medicis, the company that markets Dysport, and to Revance Therapeutics, a company developing a topical formulation of botulinum toxin. SDEF and this news organization are owned by Elsevier.

Tomorrow's approach to the aging face is all about restoring volume and moving away from filling in lines and wrinkles, according to Dr. W. Philip Werschler.

Advances in nonsurgical options such as fillers, toxins, lasers, peels, and topical products make it possible to address the volume loss and change in facial shape that comes with aging. Volume loss is cumulative through the decades and consists of several components including dermal and muscle atrophy, shifts in fat deposits, and skeletal thinning and remodeling including flattening of the maxilla, expansion of the occipital orbit, and shrinking of the mandible, he said at the seminar.

The heart shaped or trianglular appearance of a youthful face, which peaks in the mid-twenties, inverts to the pyramid of age with volumetric loss and alteration, said Dr. Werschler, an assistant clinical professor of dermatology at the University of Washington in Seattle. In women, this occurs earlier, typically in the late 40s and 50s, than in men, in the 60s and 70s. The bottom of the face appears heavier, often jowly, there is loss of the mandibular sweep, and the nose, instead of the chin, serves as the apex of the inverted triangle. Ultimately, as we age, we take on facial proportions that make us look more like infants than adults, he said.

To address wrinkles only is to address only half of the problem, Dr. Werschler said. For example, laser resurfacing can produce smooth skin in an aging patient, but they will still have a flat face, lacking in contour and dimension. If, however, nasolabial folds are tackled by volumizing the cheeks, it will lift the face and fill in the nasolabial folds, resulting in a more youthful, balanced, and natural appearance. Similarly, botulinum toxin A can be used to change the shape of the orbital opening, thus affecting crow's feet and softening eyebrows.

It is helpful to divide the face into three facial treatment zones when planning a nonsurgical total facial rejuvenation (NSYFR)--upper, mid and lower. Facial treatment zones are useful terms in patient education because they are easy to remember and easy to comprehend.

When analyzing the treatment zones, look for changes in balance, proportion, and symmetry, and consider what the patient hopes to achieve. There are many approaches to NSTFR. However, they don't exsist in isolation, and frequently the combination of NSTFR and surgery is best, according to Dr. Werschler. A good example of this is a brow lift along with laser or filler on the lips or lower part of the face. That may mean referring or collaborating with a surgeon in your practice, but the patient will thank you for the result, he said.

^{Photo Courtesy Dr. W. Philip Werschler}

Dr. Werschler is a speaker, consultant, and clinical investigator for Allergan and Medicis, and has relationships with numerous other pharmaceutical companies. SDEF and this news organization are owned by Elsevier.

Tomorrow's approach to the aging face is all about restoring volume and moving away from filling in lines and wrinkles, according to Dr. W. Philip Werschler.

Advances in nonsurgical options such as fillers, toxins, lasers, peels, and topical products make it possible to address the volume loss and change in facial shape that comes with aging. Volume loss is cumulative through the decades and consists of several components including dermal and muscle atrophy, shifts in fat deposits, and skeletal thinning and remodeling including flattening of the maxilla, expansion of the occipital orbit, and shrinking of the mandible, he said at the seminar.

The heart shaped or trianglular appearance of a youthful face, which peaks in the mid-twenties, inverts to the pyramid of age with volumetric loss and alteration, said Dr. Werschler, an assistant clinical professor of dermatology at the University of Washington in Seattle. In women, this occurs earlier, typically in the late 40s and 50s, than in men, in the 60s and 70s. The bottom of the face appears heavier, often jowly, there is loss of the mandibular sweep, and the nose, instead of the chin, serves as the apex of the inverted triangle. Ultimately, as we age, we take on facial proportions that make us look more like infants than adults, he said.

To address wrinkles only is to address only half of the problem, Dr. Werschler said. For example, laser resurfacing can produce smooth skin in an aging patient, but they will still have a flat face, lacking in contour and dimension. If, however, nasolabial folds are tackled by volumizing the cheeks, it will lift the face and fill in the nasolabial folds, resulting in a more youthful, balanced, and natural appearance. Similarly, botulinum toxin A can be used to change the shape of the orbital opening, thus affecting crow's feet and softening eyebrows.

It is helpful to divide the face into three facial treatment zones when planning a nonsurgical total facial rejuvenation (NSYFR)--upper, mid and lower. Facial treatment zones are useful terms in patient education because they are easy to remember and easy to comprehend.

When analyzing the treatment zones, look for changes in balance, proportion, and symmetry, and consider what the patient hopes to achieve. There are many approaches to NSTFR. However, they don't exsist in isolation, and frequently the combination of NSTFR and surgery is best, according to Dr. Werschler. A good example of this is a brow lift along with laser or filler on the lips or lower part of the face. That may mean referring or collaborating with a surgeon in your practice, but the patient will thank you for the result, he said.

^{Photo Courtesy Dr. W. Philip Werschler}

Dr. Werschler is a speaker, consultant, and clinical investigator for Allergan and Medicis, and has relationships with numerous other pharmaceutical companies. SDEF and this news organization are owned by Elsevier.

Tomorrow's approach to the aging face is all about restoring volume and moving away from filling in lines and wrinkles, according to Dr. W. Philip Werschler.

Advances in nonsurgical options such as fillers, toxins, lasers, peels, and topical products make it possible to address the volume loss and change in facial shape that comes with aging. Volume loss is cumulative through the decades and consists of several components including dermal and muscle atrophy, shifts in fat deposits, and skeletal thinning and remodeling including flattening of the maxilla, expansion of the occipital orbit, and shrinking of the mandible, he said at the seminar.

The heart shaped or trianglular appearance of a youthful face, which peaks in the mid-twenties, inverts to the pyramid of age with volumetric loss and alteration, said Dr. Werschler, an assistant clinical professor of dermatology at the University of Washington in Seattle. In women, this occurs earlier, typically in the late 40s and 50s, than in men, in the 60s and 70s. The bottom of the face appears heavier, often jowly, there is loss of the mandibular sweep, and the nose, instead of the chin, serves as the apex of the inverted triangle. Ultimately, as we age, we take on facial proportions that make us look more like infants than adults, he said.

To address wrinkles only is to address only half of the problem, Dr. Werschler said. For example, laser resurfacing can produce smooth skin in an aging patient, but they will still have a flat face, lacking in contour and dimension. If, however, nasolabial folds are tackled by volumizing the cheeks, it will lift the face and fill in the nasolabial folds, resulting in a more youthful, balanced, and natural appearance. Similarly, botulinum toxin A can be used to change the shape of the orbital opening, thus affecting crow's feet and softening eyebrows.

It is helpful to divide the face into three facial treatment zones when planning a nonsurgical total facial rejuvenation (NSYFR)--upper, mid and lower. Facial treatment zones are useful terms in patient education because they are easy to remember and easy to comprehend.

When analyzing the treatment zones, look for changes in balance, proportion, and symmetry, and consider what the patient hopes to achieve. There are many approaches to NSTFR. However, they don't exsist in isolation, and frequently the combination of NSTFR and surgery is best, according to Dr. Werschler. A good example of this is a brow lift along with laser or filler on the lips or lower part of the face. That may mean referring or collaborating with a surgeon in your practice, but the patient will thank you for the result, he said.

^{Photo Courtesy Dr. W. Philip Werschler}

Dr. Werschler is a speaker, consultant, and clinical investigator for Allergan and Medicis, and has relationships with numerous other pharmaceutical companies. SDEF and this news organization are owned by Elsevier.

The future of noninvasive body sculpting appears promising, as a growing number of external body-contouring technologies are awaiting approval or have recently received approval for use in the United States.

While the mechanisms by which the various technologies attack fat are different, the ultimate goal is the same: improving the appearance of problem areas such as the thighs and lower abdomen without invasive surgery, Dr. Mark G. Rubin said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

Among the devices receiving attention are the LipoSonix (Medicis) and UltraShape Contour I ultrasound-based systems, both of which have completed Food and Drug Administration trials and are awaiting an approval decision, and the Zerona low-level laser device (Erchonia), which has been approved for use, according to Dr. Rubin, a dermatologist in private practice in Beverly Hills, Calif.

The LipoSonix system, which is cleared for use in Europe and Canada, uses high-intensity, focused ultrasound to disrupt subcutaneous adipose tissue in the anterior abdomen without damaging the skin or underlying tissues and organs, according to Dr. Rubin. A transducer delivers the high intensity ultrasound at precise depths in the targeted subcutaneous adipose tissue, causing thermal coagulation of the adipose tissue, he said, noting that the damaged tissue and lipids are then transported via macrophage cells through the lymphatic system to the liver. The damaged tissue is ultimately reabsorbed over several months.

In controlled clinical studies sponsored by the manufacturer, a single, 1-hour LipoSonix treatment resulted in an average 2.8-cm reduction in waistline circumference at 8-12 weeks, although individual results vary by patient, according to Dr. Rubin.

The UltraShape Contour I system, which has also been approved for use in Europe and Canada, uses nonthermal, selective, focused ultrasound for fat reduction and body contouring, and employs an optical tracking and guidance system to help ensure the treatment is only delivered to the targeted area, Dr. Rubin explained. While the LipoSonix system achieves targeted fat cell reduction by thermal necrosis, the Ultrashape Contour I relies on initial cavitation followed by the mechanical destruction of cells.

In a multicenter, controlled, clinical study of the UltraShape Contour I system, 137 patients received a single treatment to the abdomen, flanks, or thighs. The mean circumference reduction, evaluated at 12 weeks was 2 cm, Dr. Rubin reported, noting that the majority of the effect was achieved within 2 weeks and maintained out to 12 weeks. The mean reduction in skin-fat thickness was 2.9 mm (Plast. Reconstr. Surg. 2007;120:779-89.)

"The benefits of the ultrasound devices are that they appear to have permanent fat reduction," Dr. Rubin said in an interview. In contrast, the Zerona low-level laser causes fat cells to shrink and deflate without heating the skin or causing any surrounding tissue damage, but the fat reduction is most likely temporary, he said. "The external ultrasound devices destroy fat cells, while the low-level laser drains the fat cell but it survives and can 're-inflate' again."

The reported clinical efficacy of Zerona, which requires multiple 40-minute sessions over 2 weeks, is variable. Data from a company sponsored, multisite, randomized, placebo-controlled study showed that the mean reduction of combined waist-hip-thigh circumference of patients in the treatment group was 3-4 inches, compared with a half inch in the placebo group (Lasers Surg. Med. 2009;41:799-809).

Dr. Rubin's own clinical experience with Zerona has yielded a smaller reduction. "In our experience with 41 patients, the average circumferential loss for waist, hips, and both thighs combined is 2.91 inches," he said. "There is some data suggesting laser head positioning may affect clinical results."

An advantage of Zerona is it does not create pain, inflammation, or swelling, said Dr. Rubin. It is, however, associated with more uncertainties. For example, although it consistently emulsifies the fat that it targets, "not all of the patients can successfully mobilize and degrade the fatty debris," he said. "It is believed that certain individuals, based on their lymphatic vessel structure, are unable to deliver the fat away from the interstitial space in a timely manner," which means the results will be minimal. Studies are currently underway to try to identify who the best Zerona candidates are, "but at this time the answer remains unknown," he said.

None of the devices are as effective as liposuction for fat reduction and circumferential reduction of body areas, he said. However, the devices are appealing to patients "because they are noninvasive, requiring no incisions or needles."

^{Photo Courtesy Dr. Mark G. Rubin}

Dr. Rubin is a consultant for Medicis and Zerona. SDEF and this news organization are owned by Elsevier.

The future of noninvasive body sculpting appears promising, as a growing number of external body-contouring technologies are awaiting approval or have recently received approval for use in the United States.

While the mechanisms by which the various technologies attack fat are different, the ultimate goal is the same: improving the appearance of problem areas such as the thighs and lower abdomen without invasive surgery, Dr. Mark G. Rubin said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

Among the devices receiving attention are the LipoSonix (Medicis) and UltraShape Contour I ultrasound-based systems, both of which have completed Food and Drug Administration trials and are awaiting an approval decision, and the Zerona low-level laser device (Erchonia), which has been approved for use, according to Dr. Rubin, a dermatologist in private practice in Beverly Hills, Calif.

The LipoSonix system, which is cleared for use in Europe and Canada, uses high-intensity, focused ultrasound to disrupt subcutaneous adipose tissue in the anterior abdomen without damaging the skin or underlying tissues and organs, according to Dr. Rubin. A transducer delivers the high intensity ultrasound at precise depths in the targeted subcutaneous adipose tissue, causing thermal coagulation of the adipose tissue, he said, noting that the damaged tissue and lipids are then transported via macrophage cells through the lymphatic system to the liver. The damaged tissue is ultimately reabsorbed over several months.

In controlled clinical studies sponsored by the manufacturer, a single, 1-hour LipoSonix treatment resulted in an average 2.8-cm reduction in waistline circumference at 8-12 weeks, although individual results vary by patient, according to Dr. Rubin.

The UltraShape Contour I system, which has also been approved for use in Europe and Canada, uses nonthermal, selective, focused ultrasound for fat reduction and body contouring, and employs an optical tracking and guidance system to help ensure the treatment is only delivered to the targeted area, Dr. Rubin explained. While the LipoSonix system achieves targeted fat cell reduction by thermal necrosis, the Ultrashape Contour I relies on initial cavitation followed by the mechanical destruction of cells.

In a multicenter, controlled, clinical study of the UltraShape Contour I system, 137 patients received a single treatment to the abdomen, flanks, or thighs. The mean circumference reduction, evaluated at 12 weeks was 2 cm, Dr. Rubin reported, noting that the majority of the effect was achieved within 2 weeks and maintained out to 12 weeks. The mean reduction in skin-fat thickness was 2.9 mm (Plast. Reconstr. Surg. 2007;120:779-89.)

"The benefits of the ultrasound devices are that they appear to have permanent fat reduction," Dr. Rubin said in an interview. In contrast, the Zerona low-level laser causes fat cells to shrink and deflate without heating the skin or causing any surrounding tissue damage, but the fat reduction is most likely temporary, he said. "The external ultrasound devices destroy fat cells, while the low-level laser drains the fat cell but it survives and can 're-inflate' again."

The reported clinical efficacy of Zerona, which requires multiple 40-minute sessions over 2 weeks, is variable. Data from a company sponsored, multisite, randomized, placebo-controlled study showed that the mean reduction of combined waist-hip-thigh circumference of patients in the treatment group was 3-4 inches, compared with a half inch in the placebo group (Lasers Surg. Med. 2009;41:799-809).

Dr. Rubin's own clinical experience with Zerona has yielded a smaller reduction. "In our experience with 41 patients, the average circumferential loss for waist, hips, and both thighs combined is 2.91 inches," he said. "There is some data suggesting laser head positioning may affect clinical results."

An advantage of Zerona is it does not create pain, inflammation, or swelling, said Dr. Rubin. It is, however, associated with more uncertainties. For example, although it consistently emulsifies the fat that it targets, "not all of the patients can successfully mobilize and degrade the fatty debris," he said. "It is believed that certain individuals, based on their lymphatic vessel structure, are unable to deliver the fat away from the interstitial space in a timely manner," which means the results will be minimal. Studies are currently underway to try to identify who the best Zerona candidates are, "but at this time the answer remains unknown," he said.

None of the devices are as effective as liposuction for fat reduction and circumferential reduction of body areas, he said. However, the devices are appealing to patients "because they are noninvasive, requiring no incisions or needles."

^{Photo Courtesy Dr. Mark G. Rubin}

Dr. Rubin is a consultant for Medicis and Zerona. SDEF and this news organization are owned by Elsevier.

The future of noninvasive body sculpting appears promising, as a growing number of external body-contouring technologies are awaiting approval or have recently received approval for use in the United States.

While the mechanisms by which the various technologies attack fat are different, the ultimate goal is the same: improving the appearance of problem areas such as the thighs and lower abdomen without invasive surgery, Dr. Mark G. Rubin said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

Among the devices receiving attention are the LipoSonix (Medicis) and UltraShape Contour I ultrasound-based systems, both of which have completed Food and Drug Administration trials and are awaiting an approval decision, and the Zerona low-level laser device (Erchonia), which has been approved for use, according to Dr. Rubin, a dermatologist in private practice in Beverly Hills, Calif.

The LipoSonix system, which is cleared for use in Europe and Canada, uses high-intensity, focused ultrasound to disrupt subcutaneous adipose tissue in the anterior abdomen without damaging the skin or underlying tissues and organs, according to Dr. Rubin. A transducer delivers the high intensity ultrasound at precise depths in the targeted subcutaneous adipose tissue, causing thermal coagulation of the adipose tissue, he said, noting that the damaged tissue and lipids are then transported via macrophage cells through the lymphatic system to the liver. The damaged tissue is ultimately reabsorbed over several months.

In controlled clinical studies sponsored by the manufacturer, a single, 1-hour LipoSonix treatment resulted in an average 2.8-cm reduction in waistline circumference at 8-12 weeks, although individual results vary by patient, according to Dr. Rubin.

The UltraShape Contour I system, which has also been approved for use in Europe and Canada, uses nonthermal, selective, focused ultrasound for fat reduction and body contouring, and employs an optical tracking and guidance system to help ensure the treatment is only delivered to the targeted area, Dr. Rubin explained. While the LipoSonix system achieves targeted fat cell reduction by thermal necrosis, the Ultrashape Contour I relies on initial cavitation followed by the mechanical destruction of cells.

In a multicenter, controlled, clinical study of the UltraShape Contour I system, 137 patients received a single treatment to the abdomen, flanks, or thighs. The mean circumference reduction, evaluated at 12 weeks was 2 cm, Dr. Rubin reported, noting that the majority of the effect was achieved within 2 weeks and maintained out to 12 weeks. The mean reduction in skin-fat thickness was 2.9 mm (Plast. Reconstr. Surg. 2007;120:779-89.)

"The benefits of the ultrasound devices are that they appear to have permanent fat reduction," Dr. Rubin said in an interview. In contrast, the Zerona low-level laser causes fat cells to shrink and deflate without heating the skin or causing any surrounding tissue damage, but the fat reduction is most likely temporary, he said. "The external ultrasound devices destroy fat cells, while the low-level laser drains the fat cell but it survives and can 're-inflate' again."

The reported clinical efficacy of Zerona, which requires multiple 40-minute sessions over 2 weeks, is variable. Data from a company sponsored, multisite, randomized, placebo-controlled study showed that the mean reduction of combined waist-hip-thigh circumference of patients in the treatment group was 3-4 inches, compared with a half inch in the placebo group (Lasers Surg. Med. 2009;41:799-809).

Dr. Rubin's own clinical experience with Zerona has yielded a smaller reduction. "In our experience with 41 patients, the average circumferential loss for waist, hips, and both thighs combined is 2.91 inches," he said. "There is some data suggesting laser head positioning may affect clinical results."

An advantage of Zerona is it does not create pain, inflammation, or swelling, said Dr. Rubin. It is, however, associated with more uncertainties. For example, although it consistently emulsifies the fat that it targets, "not all of the patients can successfully mobilize and degrade the fatty debris," he said. "It is believed that certain individuals, based on their lymphatic vessel structure, are unable to deliver the fat away from the interstitial space in a timely manner," which means the results will be minimal. Studies are currently underway to try to identify who the best Zerona candidates are, "but at this time the answer remains unknown," he said.

None of the devices are as effective as liposuction for fat reduction and circumferential reduction of body areas, he said. However, the devices are appealing to patients "because they are noninvasive, requiring no incisions or needles."

^{Photo Courtesy Dr. Mark G. Rubin}

Dr. Rubin is a consultant for Medicis and Zerona. SDEF and this news organization are owned by Elsevier.

With photographs of a much lighter-skinned Sammy Sosa in the media recently, questions about bleaching agents and their effects have been posed by our patients and by the media.

Skin-lightening agents are essential products for hyperpigmentation, particularly in persons of color, for whom the stigma of common skin disorders such as acne is magnified by the post-inflammatory hyperpigmentation these conditions leave as their mark. Although there are numerous skin-lightening agents on the market, including azelaic acid, mequinol, retinoids, glycolic acid, kojic acid, licorice, arbutin, soy, N-acetyl glucosamine, ascorbic acid, and niacinamide, hydroquinone (HQ) has been our workhorse.

In 1961, Dr. Malcolm C. Spencer evaluated the efficacy of hydroquinone 1.5% and 2% in 98 subjects with hyperpigmentation. Improvement was noted in 45% of subjects, with no reports of adverse events. Since this seminal study, HQ has been the standard for treatment of hyperpigmentation. HQ blocks the conversion of dihydroxyphenylalanine (DOPA) to melanin by inhibiting tyrosinase, a copper-containing enzyme of plant and animal tissues that catalyzes the production of melanin and other pigments. It may also inhibit RNA and DNA synthesis, degrade melanosomes, and destroy melanocytes.

Currently, HQ is commonly used in concentrations of 2% over the counter, 4% by standard prescription, or prescribed in higher concentrations or compounded with other agents (particularly retinoids or glycolic acid) to offer maximal efficacy. The Kligman formula, containing 5% HQ, 0.1% tretinoin, and 0.1% dexamethasone, and modifications of this formula, has emerged as the most popular combination. 

Side effects of HQ are both acute and chronic. Acute complications include irritant or allergic contact dermatitis and postinflammatory hyper- and hypopigmentation. Of these, irritant reactions are the most common. Review of the literature suggests that monotherapy hydroquinone agents cause irritant reactions in 0%-70% of patients. In combination therapy, the incidence rises to 10%-100%.  Reports of allergic contact sensitization to hydroquinone are infrequent.

Chronic adverse events related to exposure to hydroquinone are of greater concern. These complications include ochronosis, nail discoloration, conjunctival melanosis, and corneal degeneration. Ochronosis is the most common chronic complication related to long-term use of hydroquinone. The condition was initially described by G.H. Findlay and associates among South African Bantu women who applied high concentrations of hydroquinone (6%-8.5%) for many years (Br. J. Dermatol. 1975;93:613-22). Clinically, ochronosis is characterized by asymptomatic hyperpigmentation, erythema, papules, papulonodules, and grey-blue colloid milia on sun-exposed areas of the skin. Although ochronosis has been commonly described among women in Africa, it is uncommon in the United States despite its extensive use. There were less than 25 reported cases of hydroquinone-associated ochronosis in the United States in the past 25 years. Certainly, there may be unreported cases; however, conservative use of the data suggests that there would be one case of exogenous ochronosis for every 300-450 million units of hydroquinone sold in the United States. The majority of reported U.S. cases have occurred with 2% hydroquinone.

As Dr. Pearl Grimes stated in the Seminars of Cutaneous Medicine and Surgery: Skin of Color issue, “factors accounting for the disparity in the frequency of ochronosis in the U.S. and Africa include the routine use of sunscreens and the absence of resorcinol in formulations in the States. In addition, in contrast to Africa, there are few hydroethanolic formulations marketed in the U.S. Such formulations may permit enhanced absorption of HQ (2009;28:77-85). In addition, the Bantu women described in the original article by Findlay used higher concentrations of hydroquinone over extensive body surface areas, several times a day, for years or, in some cases, decades.

Hydroquinone has been banned in some countries, including over-the-counter dispensed formulations of 2% HQ by the European Cosmetic Product Regulation. In August 2006, the U.S. Food and Drug Administration (FDA) proposed a ban on OTC HQ and considered requiring new drug applications for 4% formulations due to concerns regarding ochronosis and possible carcinogenicity. Some animal studies have shown an increase in cancers that are species and sex specific, but there are no human studies documenting an increased incidence of skin cancer or internal malignancies in users of HQ.

Details on the FDA’s proposed ban are as follows: on Aug. 29, 2006, the FDA published a monograph in the U.S. Federal Register proposing that all hydroquinone products, which have not been approved through the new drug application process, be considered misbranded and therefore banned. This so-called “proposed rule” allowed anyone to submit comments to the FDA by a specified date (in this case Dec. 27, 2006 – later extended 30 days) before the so-called “final rule” would be published. Once the final rule is published in the Federal Register, manufacturers would have 30 days to remove noncompliant hydroquinone products from the marketplace or risk seizure, fines, and possibly imprisonment. Now, in 2010, the verdict on the proposed FDA ban is still pending.

 

Though controversial, hydroquinone still remains the workhorse of dermatologists for the treatment of melasma and postinflammatory hyperpigmentation. Until a safe, more widely accepted, and efficacious product is developed, we will continue the search to find the best treatment for skin of color patients.

With photographs of a much lighter-skinned Sammy Sosa in the media recently, questions about bleaching agents and their effects have been posed by our patients and by the media.

Skin-lightening agents are essential products for hyperpigmentation, particularly in persons of color, for whom the stigma of common skin disorders such as acne is magnified by the post-inflammatory hyperpigmentation these conditions leave as their mark. Although there are numerous skin-lightening agents on the market, including azelaic acid, mequinol, retinoids, glycolic acid, kojic acid, licorice, arbutin, soy, N-acetyl glucosamine, ascorbic acid, and niacinamide, hydroquinone (HQ) has been our workhorse.

In 1961, Dr. Malcolm C. Spencer evaluated the efficacy of hydroquinone 1.5% and 2% in 98 subjects with hyperpigmentation. Improvement was noted in 45% of subjects, with no reports of adverse events. Since this seminal study, HQ has been the standard for treatment of hyperpigmentation. HQ blocks the conversion of dihydroxyphenylalanine (DOPA) to melanin by inhibiting tyrosinase, a copper-containing enzyme of plant and animal tissues that catalyzes the production of melanin and other pigments. It may also inhibit RNA and DNA synthesis, degrade melanosomes, and destroy melanocytes.

Currently, HQ is commonly used in concentrations of 2% over the counter, 4% by standard prescription, or prescribed in higher concentrations or compounded with other agents (particularly retinoids or glycolic acid) to offer maximal efficacy. The Kligman formula, containing 5% HQ, 0.1% tretinoin, and 0.1% dexamethasone, and modifications of this formula, has emerged as the most popular combination. 

Side effects of HQ are both acute and chronic. Acute complications include irritant or allergic contact dermatitis and postinflammatory hyper- and hypopigmentation. Of these, irritant reactions are the most common. Review of the literature suggests that monotherapy hydroquinone agents cause irritant reactions in 0%-70% of patients. In combination therapy, the incidence rises to 10%-100%.  Reports of allergic contact sensitization to hydroquinone are infrequent.

Chronic adverse events related to exposure to hydroquinone are of greater concern. These complications include ochronosis, nail discoloration, conjunctival melanosis, and corneal degeneration. Ochronosis is the most common chronic complication related to long-term use of hydroquinone. The condition was initially described by G.H. Findlay and associates among South African Bantu women who applied high concentrations of hydroquinone (6%-8.5%) for many years (Br. J. Dermatol. 1975;93:613-22). Clinically, ochronosis is characterized by asymptomatic hyperpigmentation, erythema, papules, papulonodules, and grey-blue colloid milia on sun-exposed areas of the skin. Although ochronosis has been commonly described among women in Africa, it is uncommon in the United States despite its extensive use. There were less than 25 reported cases of hydroquinone-associated ochronosis in the United States in the past 25 years. Certainly, there may be unreported cases; however, conservative use of the data suggests that there would be one case of exogenous ochronosis for every 300-450 million units of hydroquinone sold in the United States. The majority of reported U.S. cases have occurred with 2% hydroquinone.

As Dr. Pearl Grimes stated in the Seminars of Cutaneous Medicine and Surgery: Skin of Color issue, “factors accounting for the disparity in the frequency of ochronosis in the U.S. and Africa include the routine use of sunscreens and the absence of resorcinol in formulations in the States. In addition, in contrast to Africa, there are few hydroethanolic formulations marketed in the U.S. Such formulations may permit enhanced absorption of HQ (2009;28:77-85). In addition, the Bantu women described in the original article by Findlay used higher concentrations of hydroquinone over extensive body surface areas, several times a day, for years or, in some cases, decades.

Hydroquinone has been banned in some countries, including over-the-counter dispensed formulations of 2% HQ by the European Cosmetic Product Regulation. In August 2006, the U.S. Food and Drug Administration (FDA) proposed a ban on OTC HQ and considered requiring new drug applications for 4% formulations due to concerns regarding ochronosis and possible carcinogenicity. Some animal studies have shown an increase in cancers that are species and sex specific, but there are no human studies documenting an increased incidence of skin cancer or internal malignancies in users of HQ.

Details on the FDA’s proposed ban are as follows: on Aug. 29, 2006, the FDA published a monograph in the U.S. Federal Register proposing that all hydroquinone products, which have not been approved through the new drug application process, be considered misbranded and therefore banned. This so-called “proposed rule” allowed anyone to submit comments to the FDA by a specified date (in this case Dec. 27, 2006 – later extended 30 days) before the so-called “final rule” would be published. Once the final rule is published in the Federal Register, manufacturers would have 30 days to remove noncompliant hydroquinone products from the marketplace or risk seizure, fines, and possibly imprisonment. Now, in 2010, the verdict on the proposed FDA ban is still pending.

 

Though controversial, hydroquinone still remains the workhorse of dermatologists for the treatment of melasma and postinflammatory hyperpigmentation. Until a safe, more widely accepted, and efficacious product is developed, we will continue the search to find the best treatment for skin of color patients.

With photographs of a much lighter-skinned Sammy Sosa in the media recently, questions about bleaching agents and their effects have been posed by our patients and by the media.

Skin-lightening agents are essential products for hyperpigmentation, particularly in persons of color, for whom the stigma of common skin disorders such as acne is magnified by the post-inflammatory hyperpigmentation these conditions leave as their mark. Although there are numerous skin-lightening agents on the market, including azelaic acid, mequinol, retinoids, glycolic acid, kojic acid, licorice, arbutin, soy, N-acetyl glucosamine, ascorbic acid, and niacinamide, hydroquinone (HQ) has been our workhorse.

In 1961, Dr. Malcolm C. Spencer evaluated the efficacy of hydroquinone 1.5% and 2% in 98 subjects with hyperpigmentation. Improvement was noted in 45% of subjects, with no reports of adverse events. Since this seminal study, HQ has been the standard for treatment of hyperpigmentation. HQ blocks the conversion of dihydroxyphenylalanine (DOPA) to melanin by inhibiting tyrosinase, a copper-containing enzyme of plant and animal tissues that catalyzes the production of melanin and other pigments. It may also inhibit RNA and DNA synthesis, degrade melanosomes, and destroy melanocytes.

Currently, HQ is commonly used in concentrations of 2% over the counter, 4% by standard prescription, or prescribed in higher concentrations or compounded with other agents (particularly retinoids or glycolic acid) to offer maximal efficacy. The Kligman formula, containing 5% HQ, 0.1% tretinoin, and 0.1% dexamethasone, and modifications of this formula, has emerged as the most popular combination. 

Side effects of HQ are both acute and chronic. Acute complications include irritant or allergic contact dermatitis and postinflammatory hyper- and hypopigmentation. Of these, irritant reactions are the most common. Review of the literature suggests that monotherapy hydroquinone agents cause irritant reactions in 0%-70% of patients. In combination therapy, the incidence rises to 10%-100%.  Reports of allergic contact sensitization to hydroquinone are infrequent.

Chronic adverse events related to exposure to hydroquinone are of greater concern. These complications include ochronosis, nail discoloration, conjunctival melanosis, and corneal degeneration. Ochronosis is the most common chronic complication related to long-term use of hydroquinone. The condition was initially described by G.H. Findlay and associates among South African Bantu women who applied high concentrations of hydroquinone (6%-8.5%) for many years (Br. J. Dermatol. 1975;93:613-22). Clinically, ochronosis is characterized by asymptomatic hyperpigmentation, erythema, papules, papulonodules, and grey-blue colloid milia on sun-exposed areas of the skin. Although ochronosis has been commonly described among women in Africa, it is uncommon in the United States despite its extensive use. There were less than 25 reported cases of hydroquinone-associated ochronosis in the United States in the past 25 years. Certainly, there may be unreported cases; however, conservative use of the data suggests that there would be one case of exogenous ochronosis for every 300-450 million units of hydroquinone sold in the United States. The majority of reported U.S. cases have occurred with 2% hydroquinone.

As Dr. Pearl Grimes stated in the Seminars of Cutaneous Medicine and Surgery: Skin of Color issue, “factors accounting for the disparity in the frequency of ochronosis in the U.S. and Africa include the routine use of sunscreens and the absence of resorcinol in formulations in the States. In addition, in contrast to Africa, there are few hydroethanolic formulations marketed in the U.S. Such formulations may permit enhanced absorption of HQ (2009;28:77-85). In addition, the Bantu women described in the original article by Findlay used higher concentrations of hydroquinone over extensive body surface areas, several times a day, for years or, in some cases, decades.

Hydroquinone has been banned in some countries, including over-the-counter dispensed formulations of 2% HQ by the European Cosmetic Product Regulation. In August 2006, the U.S. Food and Drug Administration (FDA) proposed a ban on OTC HQ and considered requiring new drug applications for 4% formulations due to concerns regarding ochronosis and possible carcinogenicity. Some animal studies have shown an increase in cancers that are species and sex specific, but there are no human studies documenting an increased incidence of skin cancer or internal malignancies in users of HQ.

Details on the FDA’s proposed ban are as follows: on Aug. 29, 2006, the FDA published a monograph in the U.S. Federal Register proposing that all hydroquinone products, which have not been approved through the new drug application process, be considered misbranded and therefore banned. This so-called “proposed rule” allowed anyone to submit comments to the FDA by a specified date (in this case Dec. 27, 2006 – later extended 30 days) before the so-called “final rule” would be published. Once the final rule is published in the Federal Register, manufacturers would have 30 days to remove noncompliant hydroquinone products from the marketplace or risk seizure, fines, and possibly imprisonment. Now, in 2010, the verdict on the proposed FDA ban is still pending.

 

Though controversial, hydroquinone still remains the workhorse of dermatologists for the treatment of melasma and postinflammatory hyperpigmentation. Until a safe, more widely accepted, and efficacious product is developed, we will continue the search to find the best treatment for skin of color patients.

WAIKOLOA, Hawaii — A novel topical gel formulation of botulinum toxin type A, now in the developmental pipeline, may expand the range of skin problems dermatologists can tackle with the neurotoxin.

"This is intriguing on a number of levels. I think topical therapy really could be a very good thing," Dr. Mark G. Rubin observed at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

The topical gel, being developed by Revance Pharmaceuticals, combines botulinum toxin type A with a proprietary carrier peptide that can transport the neurotoxin across the skin all the way down to the musculature.

"Without an injection we can give people results that are similar to what we see with Botox [onabotulinumtoxinA] or Dysport [abobotulinumtoxinA]," according to Dr. Rubin of the Lasky Skin Center in Beverly Hills, Calif., and the University of California, San Diego.

If the topical gel - now in early clinical trials - were eventually to win marketing approval, how might it fit into clinical practice? Certainly some patients dislike needles so much that they would prefer to sit in a physician's office with a gel on their skin for 20-30 minutes rather than get a 3-second injection and be on their way, but Dr. Rubin is unsure how many people fit that description.

There are, however, certain clinical situations where a topical preparation would offer unequivocal advantages - hyperhidrosis, for example. "Think how nice it would be to just rub a gel on instead of injecting somebody 25 times in the axilla," he said.

A topical gel would also make it easier to use the neurotoxin to treat wrinkles at difficult-to-inject sites, such as the lower eyelids.

But perhaps the most interesting potential application for a topical botulinum toxin gel is in improving the quality of the skin. Physicians who inject botulinum toxin type A have described associated reductions in skin oiliness, pore size, and facial flushing problems. Mini-doses of a topical preparation might achieve similar improvements in skin quality without the muscle weakness induced by injecting neurotoxin, the dermatologist speculated.

A 77-patient, placebo-controlled, dose-ranging clinical trial of topical botulinum gel for the treatment of crow's feet was presented last year. Participants received 1.65 ng of the neurotoxin combined with various doses of the carrier protein. Among those subjects whose neurotoxin was combined with at least 6 mcg of carrier there was an average 2-point improvement in lateral canthal lines on a 4-point scale.

"The results were fairly profound - certainly comparable to what you see with injectable Botox or Dysport," Dr. Rubin commented.

Last year in the United States 2.8 million injections of neurotoxins were performed, and more than 20,000 physicians injected Botox. Sales of injectable neurotoxins are forecast to increase by more than 15% annually, according to the dermatologist.

Dr. Rubin disclosed that he serves as a consultant to Revance and Medicis. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, Hawaii — A novel topical gel formulation of botulinum toxin type A, now in the developmental pipeline, may expand the range of skin problems dermatologists can tackle with the neurotoxin.

"This is intriguing on a number of levels. I think topical therapy really could be a very good thing," Dr. Mark G. Rubin observed at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

The topical gel, being developed by Revance Pharmaceuticals, combines botulinum toxin type A with a proprietary carrier peptide that can transport the neurotoxin across the skin all the way down to the musculature.

"Without an injection we can give people results that are similar to what we see with Botox [onabotulinumtoxinA] or Dysport [abobotulinumtoxinA]," according to Dr. Rubin of the Lasky Skin Center in Beverly Hills, Calif., and the University of California, San Diego.

If the topical gel - now in early clinical trials - were eventually to win marketing approval, how might it fit into clinical practice? Certainly some patients dislike needles so much that they would prefer to sit in a physician's office with a gel on their skin for 20-30 minutes rather than get a 3-second injection and be on their way, but Dr. Rubin is unsure how many people fit that description.

There are, however, certain clinical situations where a topical preparation would offer unequivocal advantages - hyperhidrosis, for example. "Think how nice it would be to just rub a gel on instead of injecting somebody 25 times in the axilla," he said.

A topical gel would also make it easier to use the neurotoxin to treat wrinkles at difficult-to-inject sites, such as the lower eyelids.

But perhaps the most interesting potential application for a topical botulinum toxin gel is in improving the quality of the skin. Physicians who inject botulinum toxin type A have described associated reductions in skin oiliness, pore size, and facial flushing problems. Mini-doses of a topical preparation might achieve similar improvements in skin quality without the muscle weakness induced by injecting neurotoxin, the dermatologist speculated.

A 77-patient, placebo-controlled, dose-ranging clinical trial of topical botulinum gel for the treatment of crow's feet was presented last year. Participants received 1.65 ng of the neurotoxin combined with various doses of the carrier protein. Among those subjects whose neurotoxin was combined with at least 6 mcg of carrier there was an average 2-point improvement in lateral canthal lines on a 4-point scale.

"The results were fairly profound - certainly comparable to what you see with injectable Botox or Dysport," Dr. Rubin commented.

Last year in the United States 2.8 million injections of neurotoxins were performed, and more than 20,000 physicians injected Botox. Sales of injectable neurotoxins are forecast to increase by more than 15% annually, according to the dermatologist.

Dr. Rubin disclosed that he serves as a consultant to Revance and Medicis. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, Hawaii — A novel topical gel formulation of botulinum toxin type A, now in the developmental pipeline, may expand the range of skin problems dermatologists can tackle with the neurotoxin.

"This is intriguing on a number of levels. I think topical therapy really could be a very good thing," Dr. Mark G. Rubin observed at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

The topical gel, being developed by Revance Pharmaceuticals, combines botulinum toxin type A with a proprietary carrier peptide that can transport the neurotoxin across the skin all the way down to the musculature.

"Without an injection we can give people results that are similar to what we see with Botox [onabotulinumtoxinA] or Dysport [abobotulinumtoxinA]," according to Dr. Rubin of the Lasky Skin Center in Beverly Hills, Calif., and the University of California, San Diego.

If the topical gel - now in early clinical trials - were eventually to win marketing approval, how might it fit into clinical practice? Certainly some patients dislike needles so much that they would prefer to sit in a physician's office with a gel on their skin for 20-30 minutes rather than get a 3-second injection and be on their way, but Dr. Rubin is unsure how many people fit that description.

There are, however, certain clinical situations where a topical preparation would offer unequivocal advantages - hyperhidrosis, for example. "Think how nice it would be to just rub a gel on instead of injecting somebody 25 times in the axilla," he said.

A topical gel would also make it easier to use the neurotoxin to treat wrinkles at difficult-to-inject sites, such as the lower eyelids.

But perhaps the most interesting potential application for a topical botulinum toxin gel is in improving the quality of the skin. Physicians who inject botulinum toxin type A have described associated reductions in skin oiliness, pore size, and facial flushing problems. Mini-doses of a topical preparation might achieve similar improvements in skin quality without the muscle weakness induced by injecting neurotoxin, the dermatologist speculated.

A 77-patient, placebo-controlled, dose-ranging clinical trial of topical botulinum gel for the treatment of crow's feet was presented last year. Participants received 1.65 ng of the neurotoxin combined with various doses of the carrier protein. Among those subjects whose neurotoxin was combined with at least 6 mcg of carrier there was an average 2-point improvement in lateral canthal lines on a 4-point scale.

"The results were fairly profound - certainly comparable to what you see with injectable Botox or Dysport," Dr. Rubin commented.

Last year in the United States 2.8 million injections of neurotoxins were performed, and more than 20,000 physicians injected Botox. Sales of injectable neurotoxins are forecast to increase by more than 15% annually, according to the dermatologist.

Dr. Rubin disclosed that he serves as a consultant to Revance and Medicis. SDEF and this news organization are owned by Elsevier.

The lifetime risk of white patients developing melanoma is currently estimated at 1 in 50, compared with 1 in 1,000 for black patients. Although darker-pigmented populations are consistently reported to have lower melanoma risk--possibly related to protection from ultraviolet radiation provided by melanin--darker skinned patients have been consistently shown to have worse outcomes than whites.

While less common in blacks, malignant melanoma is nonetheless an aggressive, deadly disease and presents at a more advanced stage at diagnosis and with a decreased chance of survival than in white patints. Underlying etiologies for the disparity in prognosis are still poorly understood.

Many of the public health interventions for melanoma prevention have focused predominantly on whites. However, recent studies in blacks and Hispanics that have elucidated advanced stage of melanoma at presentation and a higher mortality rate have led to increased efforts to characterize melanoma in ethnic minorities.

One such study found that ethnic disparities persist in the incidence of melanoma and its stage at diagnosis (Arch Dermatol. 2009;145:1369-74). Researchers analyzed information in the Florida Cancer Data System, a statewide, population-based cancer registry. They looked at three 5-year periods: 1990 to 1994, 1995 to 1999, and 2000 to 2004.

Of 41,072 cases of melanoma diagnosed from 1990 to 2004, 39,670 were in whites, 1,148 in Hispanics, and 254 in blacks. Advanced melanoma diagnosed at either regional or distant stages were seen in 26.4% of black patients, compared with 17.8% of Hispanics and 11.6% of whites. Blacks and Hispanic patients had advanced cancer odd ratios of 2.7 and 1.6, respectively, compared with whites.

The authors of the study concluded that public health efforts are one of the primary sources of ethnic disparities. However the question still remains: is race (and in essence a more aggressive tumor biology) an independent prognostic indicator? 

Multiple studies have elucidated worse prognosis in blacks even when controlling for socioeconomic status, stage, tumor thickness, ulceration, anatomic site, and histological type. This data has been refuted in other studies that show no survival advantage in whites; however, the controversy still remains.

This study is a much needed reminder that increased surveillance is needed, as well as more targeted public health efforts, prevention models, and educational programs specific to the culture and languages of ethnic groups. We also need to continue to investigate the unique genetic and biologic markers of melanoma in different ethnic populations to improve clinical detection and develop targeted therapies.

The lifetime risk of white patients developing melanoma is currently estimated at 1 in 50, compared with 1 in 1,000 for black patients. Although darker-pigmented populations are consistently reported to have lower melanoma risk--possibly related to protection from ultraviolet radiation provided by melanin--darker skinned patients have been consistently shown to have worse outcomes than whites.

While less common in blacks, malignant melanoma is nonetheless an aggressive, deadly disease and presents at a more advanced stage at diagnosis and with a decreased chance of survival than in white patints. Underlying etiologies for the disparity in prognosis are still poorly understood.

Many of the public health interventions for melanoma prevention have focused predominantly on whites. However, recent studies in blacks and Hispanics that have elucidated advanced stage of melanoma at presentation and a higher mortality rate have led to increased efforts to characterize melanoma in ethnic minorities.

One such study found that ethnic disparities persist in the incidence of melanoma and its stage at diagnosis (Arch Dermatol. 2009;145:1369-74). Researchers analyzed information in the Florida Cancer Data System, a statewide, population-based cancer registry. They looked at three 5-year periods: 1990 to 1994, 1995 to 1999, and 2000 to 2004.

Of 41,072 cases of melanoma diagnosed from 1990 to 2004, 39,670 were in whites, 1,148 in Hispanics, and 254 in blacks. Advanced melanoma diagnosed at either regional or distant stages were seen in 26.4% of black patients, compared with 17.8% of Hispanics and 11.6% of whites. Blacks and Hispanic patients had advanced cancer odd ratios of 2.7 and 1.6, respectively, compared with whites.

The authors of the study concluded that public health efforts are one of the primary sources of ethnic disparities. However the question still remains: is race (and in essence a more aggressive tumor biology) an independent prognostic indicator? 

Multiple studies have elucidated worse prognosis in blacks even when controlling for socioeconomic status, stage, tumor thickness, ulceration, anatomic site, and histological type. This data has been refuted in other studies that show no survival advantage in whites; however, the controversy still remains.

This study is a much needed reminder that increased surveillance is needed, as well as more targeted public health efforts, prevention models, and educational programs specific to the culture and languages of ethnic groups. We also need to continue to investigate the unique genetic and biologic markers of melanoma in different ethnic populations to improve clinical detection and develop targeted therapies.

The lifetime risk of white patients developing melanoma is currently estimated at 1 in 50, compared with 1 in 1,000 for black patients. Although darker-pigmented populations are consistently reported to have lower melanoma risk--possibly related to protection from ultraviolet radiation provided by melanin--darker skinned patients have been consistently shown to have worse outcomes than whites.

While less common in blacks, malignant melanoma is nonetheless an aggressive, deadly disease and presents at a more advanced stage at diagnosis and with a decreased chance of survival than in white patints. Underlying etiologies for the disparity in prognosis are still poorly understood.

Many of the public health interventions for melanoma prevention have focused predominantly on whites. However, recent studies in blacks and Hispanics that have elucidated advanced stage of melanoma at presentation and a higher mortality rate have led to increased efforts to characterize melanoma in ethnic minorities.

One such study found that ethnic disparities persist in the incidence of melanoma and its stage at diagnosis (Arch Dermatol. 2009;145:1369-74). Researchers analyzed information in the Florida Cancer Data System, a statewide, population-based cancer registry. They looked at three 5-year periods: 1990 to 1994, 1995 to 1999, and 2000 to 2004.

Of 41,072 cases of melanoma diagnosed from 1990 to 2004, 39,670 were in whites, 1,148 in Hispanics, and 254 in blacks. Advanced melanoma diagnosed at either regional or distant stages were seen in 26.4% of black patients, compared with 17.8% of Hispanics and 11.6% of whites. Blacks and Hispanic patients had advanced cancer odd ratios of 2.7 and 1.6, respectively, compared with whites.

The authors of the study concluded that public health efforts are one of the primary sources of ethnic disparities. However the question still remains: is race (and in essence a more aggressive tumor biology) an independent prognostic indicator? 

Multiple studies have elucidated worse prognosis in blacks even when controlling for socioeconomic status, stage, tumor thickness, ulceration, anatomic site, and histological type. This data has been refuted in other studies that show no survival advantage in whites; however, the controversy still remains.

This study is a much needed reminder that increased surveillance is needed, as well as more targeted public health efforts, prevention models, and educational programs specific to the culture and languages of ethnic groups. We also need to continue to investigate the unique genetic and biologic markers of melanoma in different ethnic populations to improve clinical detection and develop targeted therapies.

ORLANDO, Fla. – Growing numbers of patients with deeper skin tones are seeking cosmetic procedures involving injectable fillers.

“Many women of color do not have fine lines and wrinkles; they have loss of volume of the skin with

descent of the malar fat pads, prominence of the nasolabial folds, and prominence of the tear troughs, so those are the very areas that are appropriate for injections in women with skin of color, and men as well,” said Dr. Susan Taylor at the Orlando Dermatology Aesthetic and Clinical Conference.

Dr. Taylor, who helped to establish the Skin of Color Center at St. Luke’s–Roosevelt Hospital Center (N.Y.), is now in private practice in Philadelphia. She reviewed the characteristics of aging in patients with skin of color and evidence for the safe use of fillers in these patients.

Patients with skin of color often appear about 10 years younger than white patients of the same age, Dr. Taylor noted. As patients with skin of color age, they tend to have fewer fine and deep rhytids than white patients. But patients with deeper skin tones in their 40s and 50s do experience gravity-dependent changes and volume loss, as well as skeletal changes and soft tissue changes. Thus, these transformations lend themselves to treatment with injectable fillers.

“The options for your skin of color patients are the same options that you have for Caucasian patients,” Dr. Taylor said.

But is it just as safe for persons of color as it is for patients with fair skin? “We know that keloidal scarring develops 3-18 times as often in African American patients as in Caucasian patients,” said Dr. Taylor.

Potential adverse events from soft tissue fillers in patients with Fitzpatrick skin types IV, V, and VI could include postinflammatory hyperpigmentation, postinflammatory hypopigmentation, keloidal scarring, and hypertrophic scarring.

The Food and Drug Administration has conducted postapproval safety studies in Fitzpatrick skin types IV (brown), V (dark brown), and VI (deepest brown to black) for nine dermal fillers, including Restylane, Perlane, and Sculptra, Dr. Taylor said.

Data from three postapproval studies of three fillers each showed that none of the patients with skin of color had hypersensitivity reactions or developed keloids after one or two injections of any of the fillers. Patients in the studies were followed for up to 6 months, approximately.

Overall, 20 (6%) of the 369 patients across the studies developed hyperpigmentation, and 1 developed hypopigmentation, Dr. Taylor said.

“The pigmentation changes were very subtle,” she said.

Changes in pigmentation after injecting fillers in skin or color patients may be due to injection techniques, the use of concomitant anesthesia, or the specific product, Dr. Taylor said.

She advised physicians to look carefully at a patient’s skin prior to injecting any filler to document any pigmentation that was already present to help determine sensitivity and guide their injections techniques accordingly.

There were limitations to the postapproval studies, including the lack of controls and relatively short-term follow-up, and the need for more data.

“But what we can say now is that it’s very important that you warn your patients about the possibility of postinflammatory hyperpigmentation in particular, although hypopigmentation can occur,” Dr. Taylor said. Inform patients that there is a theoretical risk of keloidal scarring, but there have been no reports of keloids in the literature, she added.

To reduce the risk of hyperpigmentation, try a linear threading technique or injecting a bit more deeply to reduce the risk of hyperpigmentation, and note any pigmentation changes over a long-term follow-up period, she said.

Dr. Taylor has served as an investigator, speaker, and/or advisory board member for Allergan, Bioform, Genzyme, Johnson & Johnson, Medicis, Mentor, and Merz.

_{Image above is of Dr. Susan Taylor/Photo Credit: Heidi Splete}

ORLANDO, Fla. – Growing numbers of patients with deeper skin tones are seeking cosmetic procedures involving injectable fillers.

“Many women of color do not have fine lines and wrinkles; they have loss of volume of the skin with

descent of the malar fat pads, prominence of the nasolabial folds, and prominence of the tear troughs, so those are the very areas that are appropriate for injections in women with skin of color, and men as well,” said Dr. Susan Taylor at the Orlando Dermatology Aesthetic and Clinical Conference.

Dr. Taylor, who helped to establish the Skin of Color Center at St. Luke’s–Roosevelt Hospital Center (N.Y.), is now in private practice in Philadelphia. She reviewed the characteristics of aging in patients with skin of color and evidence for the safe use of fillers in these patients.

Patients with skin of color often appear about 10 years younger than white patients of the same age, Dr. Taylor noted. As patients with skin of color age, they tend to have fewer fine and deep rhytids than white patients. But patients with deeper skin tones in their 40s and 50s do experience gravity-dependent changes and volume loss, as well as skeletal changes and soft tissue changes. Thus, these transformations lend themselves to treatment with injectable fillers.

“The options for your skin of color patients are the same options that you have for Caucasian patients,” Dr. Taylor said.

But is it just as safe for persons of color as it is for patients with fair skin? “We know that keloidal scarring develops 3-18 times as often in African American patients as in Caucasian patients,” said Dr. Taylor.

Potential adverse events from soft tissue fillers in patients with Fitzpatrick skin types IV, V, and VI could include postinflammatory hyperpigmentation, postinflammatory hypopigmentation, keloidal scarring, and hypertrophic scarring.

The Food and Drug Administration has conducted postapproval safety studies in Fitzpatrick skin types IV (brown), V (dark brown), and VI (deepest brown to black) for nine dermal fillers, including Restylane, Perlane, and Sculptra, Dr. Taylor said.

Data from three postapproval studies of three fillers each showed that none of the patients with skin of color had hypersensitivity reactions or developed keloids after one or two injections of any of the fillers. Patients in the studies were followed for up to 6 months, approximately.

Overall, 20 (6%) of the 369 patients across the studies developed hyperpigmentation, and 1 developed hypopigmentation, Dr. Taylor said.

“The pigmentation changes were very subtle,” she said.

Changes in pigmentation after injecting fillers in skin or color patients may be due to injection techniques, the use of concomitant anesthesia, or the specific product, Dr. Taylor said.

She advised physicians to look carefully at a patient’s skin prior to injecting any filler to document any pigmentation that was already present to help determine sensitivity and guide their injections techniques accordingly.

There were limitations to the postapproval studies, including the lack of controls and relatively short-term follow-up, and the need for more data.

“But what we can say now is that it’s very important that you warn your patients about the possibility of postinflammatory hyperpigmentation in particular, although hypopigmentation can occur,” Dr. Taylor said. Inform patients that there is a theoretical risk of keloidal scarring, but there have been no reports of keloids in the literature, she added.

To reduce the risk of hyperpigmentation, try a linear threading technique or injecting a bit more deeply to reduce the risk of hyperpigmentation, and note any pigmentation changes over a long-term follow-up period, she said.

Dr. Taylor has served as an investigator, speaker, and/or advisory board member for Allergan, Bioform, Genzyme, Johnson & Johnson, Medicis, Mentor, and Merz.

_{Image above is of Dr. Susan Taylor/Photo Credit: Heidi Splete}

ORLANDO, Fla. – Growing numbers of patients with deeper skin tones are seeking cosmetic procedures involving injectable fillers.

“Many women of color do not have fine lines and wrinkles; they have loss of volume of the skin with

descent of the malar fat pads, prominence of the nasolabial folds, and prominence of the tear troughs, so those are the very areas that are appropriate for injections in women with skin of color, and men as well,” said Dr. Susan Taylor at the Orlando Dermatology Aesthetic and Clinical Conference.

Dr. Taylor, who helped to establish the Skin of Color Center at St. Luke’s–Roosevelt Hospital Center (N.Y.), is now in private practice in Philadelphia. She reviewed the characteristics of aging in patients with skin of color and evidence for the safe use of fillers in these patients.

Patients with skin of color often appear about 10 years younger than white patients of the same age, Dr. Taylor noted. As patients with skin of color age, they tend to have fewer fine and deep rhytids than white patients. But patients with deeper skin tones in their 40s and 50s do experience gravity-dependent changes and volume loss, as well as skeletal changes and soft tissue changes. Thus, these transformations lend themselves to treatment with injectable fillers.

“The options for your skin of color patients are the same options that you have for Caucasian patients,” Dr. Taylor said.

But is it just as safe for persons of color as it is for patients with fair skin? “We know that keloidal scarring develops 3-18 times as often in African American patients as in Caucasian patients,” said Dr. Taylor.

Potential adverse events from soft tissue fillers in patients with Fitzpatrick skin types IV, V, and VI could include postinflammatory hyperpigmentation, postinflammatory hypopigmentation, keloidal scarring, and hypertrophic scarring.

The Food and Drug Administration has conducted postapproval safety studies in Fitzpatrick skin types IV (brown), V (dark brown), and VI (deepest brown to black) for nine dermal fillers, including Restylane, Perlane, and Sculptra, Dr. Taylor said.

Data from three postapproval studies of three fillers each showed that none of the patients with skin of color had hypersensitivity reactions or developed keloids after one or two injections of any of the fillers. Patients in the studies were followed for up to 6 months, approximately.

Overall, 20 (6%) of the 369 patients across the studies developed hyperpigmentation, and 1 developed hypopigmentation, Dr. Taylor said.

“The pigmentation changes were very subtle,” she said.

Changes in pigmentation after injecting fillers in skin or color patients may be due to injection techniques, the use of concomitant anesthesia, or the specific product, Dr. Taylor said.

She advised physicians to look carefully at a patient’s skin prior to injecting any filler to document any pigmentation that was already present to help determine sensitivity and guide their injections techniques accordingly.

There were limitations to the postapproval studies, including the lack of controls and relatively short-term follow-up, and the need for more data.

“But what we can say now is that it’s very important that you warn your patients about the possibility of postinflammatory hyperpigmentation in particular, although hypopigmentation can occur,” Dr. Taylor said. Inform patients that there is a theoretical risk of keloidal scarring, but there have been no reports of keloids in the literature, she added.

To reduce the risk of hyperpigmentation, try a linear threading technique or injecting a bit more deeply to reduce the risk of hyperpigmentation, and note any pigmentation changes over a long-term follow-up period, she said.

Dr. Taylor has served as an investigator, speaker, and/or advisory board member for Allergan, Bioform, Genzyme, Johnson & Johnson, Medicis, Mentor, and Merz.

_{Image above is of Dr. Susan Taylor/Photo Credit: Heidi Splete}

ORLANDO - Laser-assisted liposuction appears to be safer than power-assisted liposuction, leaving patients with significantly fewer complications and side effects by 3 months.

Patients undergoing the laser-assisted procedure also requested significantly fewer revisions, Dr. Jeffry B. Schafer said at the annual meeting of the American Academy of Cosmetic Surgery.

The laser exerts a dual effect - fat removal and skin tightening - in one procedure, Dr. Schafer said in an interview. "The laser gives you smoothing by melting the fat and tightens the skin by heating the collagen so you get tighter skin, eliminating both lumps and loose skin - the complaints after lipo," he said.

He reported a retrospective study of 214 patients treated with liposuction; half underwent the traditional, power- or suction-assisted liposuction (PAL), and half underwent laser-assisted liposuction (LAL).

During LAL, Dr. Schafer uses a 4-mm Mercedes cannula with a dual wavelength laser (924 nm and 975 nm). He uses both settings at the highest power and makes two lasing passes. "The first pass is to soften and remove the adipose tissue, and the second pass is right beneath the skin, to tighten the collagen," he said. He uses a handheld infrared thermometer to monitor the temperature; it should be at about 35ºC to liquify the fat, and 40ºC to affect the collagen.

The 107 PAL patients were a mean of 40 years old, with a mean body mass index of 27 kg/m2. The 107 LAL patients were not significantly different: their mean age was 38, and their mean BMI was 28 kg/m2.

The mean tumescent anesthesia volume used in the LAL group was 3,756 cc; the mean volume in the PAL group was 4,485 cc. Mean procedure time was slightly longer in the LAL group (57 vs. 46 minutes), because of the additional 27-minute lasing time. Actual suction time in the LAL group was 32 minutes.

Lasing time in the LAL group varied with the wattage system, Dr. Schafer pointed out. "That time is reduced by about 6 minutes if using the 40-watt system compared to the 24-watt system. So the lasing time could be about 21 minutes instead of 27 minutes if using 40 watts."

Side effects were described as an anticipated reaction that resolved without medical intervention, and included hardness, swelling, and abrasions. Overall, side effects were significantly less common in the LAL group at both 1 month (16% vs. 56%) and 3 months (12% vs. 54%). Hardness was the most commonly reported, occurring in 11% of the LAL group and 54% of the PAL group.

Complications were described as anticipated reactions that may not resolve with medical intervention, and included seroma, scar tissue, loose skin, and irregularity in skin surface. At 1 month, the complication rate was similar (4% LAL vs. 3% PAL). By 3 months, the rate was significantly less in the LAL group than in the PAL group (3% vs. 13%). Seroma was more common in the LAL group both at 1 month (3% vs. 1%) and 3 months (2% vs. 0%). At 3 months, scar tissue occurred in 1% of the LAL group and 3% of the PAL group. Also at 3 months, fewer LAL patients reported loose skin (0% vs. 8%).

Revisions were significantly less common in the LAL group (4 vs. 73). "Fewer revisions mean less patient hand-holding in the post treatment period," Dr. Schafer said.

Some samples of the aspirate were sent for stem cell extraction. Under gross observation, the fat extracted with LAL appeared smoother, Dr. Schafer said.

Histology showed intact membranes on the adipocytes; cell membranes in the PAL-extracted samples were ruptured. "Aspirate with LAL is more homogenous with higher fat content than PAL," Dr. Schafer said. "Melting from laser leaves much smoother skin, fewer contour issues, less lipo filling, and a high degree of skin tightening." Maintaining intact adipocytes is also critical if the fat is to be used in a transfer, he added.

Dr. Schafer is in private practice in Coronado, Calif. He disclosed that he helped develop the SlimLipo machine, which he used in the study. He is also a teacher and speaker for Palomar Medical Technologies Inc., the Burlington, Mass., company that developed the system.

ORLANDO - Laser-assisted liposuction appears to be safer than power-assisted liposuction, leaving patients with significantly fewer complications and side effects by 3 months.

Patients undergoing the laser-assisted procedure also requested significantly fewer revisions, Dr. Jeffry B. Schafer said at the annual meeting of the American Academy of Cosmetic Surgery.

The laser exerts a dual effect - fat removal and skin tightening - in one procedure, Dr. Schafer said in an interview. "The laser gives you smoothing by melting the fat and tightens the skin by heating the collagen so you get tighter skin, eliminating both lumps and loose skin - the complaints after lipo," he said.

He reported a retrospective study of 214 patients treated with liposuction; half underwent the traditional, power- or suction-assisted liposuction (PAL), and half underwent laser-assisted liposuction (LAL).

During LAL, Dr. Schafer uses a 4-mm Mercedes cannula with a dual wavelength laser (924 nm and 975 nm). He uses both settings at the highest power and makes two lasing passes. "The first pass is to soften and remove the adipose tissue, and the second pass is right beneath the skin, to tighten the collagen," he said. He uses a handheld infrared thermometer to monitor the temperature; it should be at about 35ºC to liquify the fat, and 40ºC to affect the collagen.

The 107 PAL patients were a mean of 40 years old, with a mean body mass index of 27 kg/m2. The 107 LAL patients were not significantly different: their mean age was 38, and their mean BMI was 28 kg/m2.

The mean tumescent anesthesia volume used in the LAL group was 3,756 cc; the mean volume in the PAL group was 4,485 cc. Mean procedure time was slightly longer in the LAL group (57 vs. 46 minutes), because of the additional 27-minute lasing time. Actual suction time in the LAL group was 32 minutes.

Lasing time in the LAL group varied with the wattage system, Dr. Schafer pointed out. "That time is reduced by about 6 minutes if using the 40-watt system compared to the 24-watt system. So the lasing time could be about 21 minutes instead of 27 minutes if using 40 watts."

Side effects were described as an anticipated reaction that resolved without medical intervention, and included hardness, swelling, and abrasions. Overall, side effects were significantly less common in the LAL group at both 1 month (16% vs. 56%) and 3 months (12% vs. 54%). Hardness was the most commonly reported, occurring in 11% of the LAL group and 54% of the PAL group.

Complications were described as anticipated reactions that may not resolve with medical intervention, and included seroma, scar tissue, loose skin, and irregularity in skin surface. At 1 month, the complication rate was similar (4% LAL vs. 3% PAL). By 3 months, the rate was significantly less in the LAL group than in the PAL group (3% vs. 13%). Seroma was more common in the LAL group both at 1 month (3% vs. 1%) and 3 months (2% vs. 0%). At 3 months, scar tissue occurred in 1% of the LAL group and 3% of the PAL group. Also at 3 months, fewer LAL patients reported loose skin (0% vs. 8%).

Revisions were significantly less common in the LAL group (4 vs. 73). "Fewer revisions mean less patient hand-holding in the post treatment period," Dr. Schafer said.

Some samples of the aspirate were sent for stem cell extraction. Under gross observation, the fat extracted with LAL appeared smoother, Dr. Schafer said.

Histology showed intact membranes on the adipocytes; cell membranes in the PAL-extracted samples were ruptured. "Aspirate with LAL is more homogenous with higher fat content than PAL," Dr. Schafer said. "Melting from laser leaves much smoother skin, fewer contour issues, less lipo filling, and a high degree of skin tightening." Maintaining intact adipocytes is also critical if the fat is to be used in a transfer, he added.

Dr. Schafer is in private practice in Coronado, Calif. He disclosed that he helped develop the SlimLipo machine, which he used in the study. He is also a teacher and speaker for Palomar Medical Technologies Inc., the Burlington, Mass., company that developed the system.

ORLANDO - Laser-assisted liposuction appears to be safer than power-assisted liposuction, leaving patients with significantly fewer complications and side effects by 3 months.

Patients undergoing the laser-assisted procedure also requested significantly fewer revisions, Dr. Jeffry B. Schafer said at the annual meeting of the American Academy of Cosmetic Surgery.

The laser exerts a dual effect - fat removal and skin tightening - in one procedure, Dr. Schafer said in an interview. "The laser gives you smoothing by melting the fat and tightens the skin by heating the collagen so you get tighter skin, eliminating both lumps and loose skin - the complaints after lipo," he said.

He reported a retrospective study of 214 patients treated with liposuction; half underwent the traditional, power- or suction-assisted liposuction (PAL), and half underwent laser-assisted liposuction (LAL).

During LAL, Dr. Schafer uses a 4-mm Mercedes cannula with a dual wavelength laser (924 nm and 975 nm). He uses both settings at the highest power and makes two lasing passes. "The first pass is to soften and remove the adipose tissue, and the second pass is right beneath the skin, to tighten the collagen," he said. He uses a handheld infrared thermometer to monitor the temperature; it should be at about 35ºC to liquify the fat, and 40ºC to affect the collagen.

The 107 PAL patients were a mean of 40 years old, with a mean body mass index of 27 kg/m2. The 107 LAL patients were not significantly different: their mean age was 38, and their mean BMI was 28 kg/m2.

The mean tumescent anesthesia volume used in the LAL group was 3,756 cc; the mean volume in the PAL group was 4,485 cc. Mean procedure time was slightly longer in the LAL group (57 vs. 46 minutes), because of the additional 27-minute lasing time. Actual suction time in the LAL group was 32 minutes.

Lasing time in the LAL group varied with the wattage system, Dr. Schafer pointed out. "That time is reduced by about 6 minutes if using the 40-watt system compared to the 24-watt system. So the lasing time could be about 21 minutes instead of 27 minutes if using 40 watts."

Side effects were described as an anticipated reaction that resolved without medical intervention, and included hardness, swelling, and abrasions. Overall, side effects were significantly less common in the LAL group at both 1 month (16% vs. 56%) and 3 months (12% vs. 54%). Hardness was the most commonly reported, occurring in 11% of the LAL group and 54% of the PAL group.

Complications were described as anticipated reactions that may not resolve with medical intervention, and included seroma, scar tissue, loose skin, and irregularity in skin surface. At 1 month, the complication rate was similar (4% LAL vs. 3% PAL). By 3 months, the rate was significantly less in the LAL group than in the PAL group (3% vs. 13%). Seroma was more common in the LAL group both at 1 month (3% vs. 1%) and 3 months (2% vs. 0%). At 3 months, scar tissue occurred in 1% of the LAL group and 3% of the PAL group. Also at 3 months, fewer LAL patients reported loose skin (0% vs. 8%).

Revisions were significantly less common in the LAL group (4 vs. 73). "Fewer revisions mean less patient hand-holding in the post treatment period," Dr. Schafer said.

Some samples of the aspirate were sent for stem cell extraction. Under gross observation, the fat extracted with LAL appeared smoother, Dr. Schafer said.

Histology showed intact membranes on the adipocytes; cell membranes in the PAL-extracted samples were ruptured. "Aspirate with LAL is more homogenous with higher fat content than PAL," Dr. Schafer said. "Melting from laser leaves much smoother skin, fewer contour issues, less lipo filling, and a high degree of skin tightening." Maintaining intact adipocytes is also critical if the fat is to be used in a transfer, he added.

Dr. Schafer is in private practice in Coronado, Calif. He disclosed that he helped develop the SlimLipo machine, which he used in the study. He is also a teacher and speaker for Palomar Medical Technologies Inc., the Burlington, Mass., company that developed the system.