Pigmentation Disorders

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don't know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009;48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy, and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don't know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009;48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy, and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

NEW ORLEANS - Treatment for melasma can be effective, although the search continues for the ideal clinical strategy that yields optimal outcomes with minimal adverse effects, according to Dr. Amit G. Pandya.

The first challenge is to get patients into treatment. "There is a huge number of people out there with melasma who we are not seeing. A lot are being treated with over-the-counter products or are not being treated [at all]," he said at the annual meeting of the American Academy of Dermatology.

Melasma is a common condition. For example, Dr. Pandya and his colleagues found in a telephone survey that 8.8% of Latino women in the Dallas and Fort Worth, Texas, areas reported melasma (Arch. Dermatol. 2007;143:424-5).

"If I had a buck for each case of melasma, I could retire already," said session moderator Dr. Harvey Lui, professor and chair of dermatology and skin science at the University of British Columbia, Vancouver. "I just don't know what to do with these patients."

Much of the treatment and management of melasma rely on physicians' clinical expertise. "The evidence we have out there is not huge," Dr. Pandya said. He is professor of dermatology at the University of Texas Southwestern Medical Center at Dallas.

The differential diagnosis includes ruling out postinflammatory hyperpigmentation and drug-induced photosensitivity. Also, "with the growing obesity epidemic, we also see more acanthosis nigricans on the face," Dr. Pandya said.

Treatment of melasma is important – whether it be with a hydroquinone preparation, a chemical peel, or microdermabrasion – because it improves quality of life for patients living with melasma, Dr. Pandya said. Multiple studies have demonstrated that melasma can have a significant negative effect on a person's social life, recreation and leisure activities, and emotional well-being (Brit. J. Dermatol. 2003;149:572-7; J. Am. Acad. Dermatol. 2006;55:59-66).

Dioic acid is a new treatment showing promise in the treatment of melasma, Dr. Pandya said. He cited results of a study of 96 Mexican females treated with 1% dioic acid cream twice daily vs. 2% hydroquinone cream twice daily (Int. J. Dermatol. 2009;48:893-5). After 12 weeks, both treatments were associated with significant decreases in Melasma Area Severity Index (MASI) scores. There were no significant differences in efficacy, and adverse events were similar, except for more pruritus associated with hydroquinone treatment. "This may be an agent we can use in the future," Dr. Pandya said.

Oral antioxidants for melasma also showed promise in a randomized, double-blind, placebo-controlled trial (Int. J. Dermatol. 2009;48:896-901). Researchers assessed a combination of oral procyanidin (a component of pine bark) plus vitamins A, C, and E in 60 women with bilateral epidermal melasma. Study participants took either the oral treatment or a placebo twice daily with meals for 8 weeks. Clinicians observed significant reductions, compared with baseline in pigmentation and significant improvements in MASI scores in the malar regions of faces treated with the antioxidants vs. placebo. The investigators said the combination was well tolerated with minimal side effects.

"This may be something else we can use in the future," Dr. Pandya said.

The tyrosine inhibitor hydroquinone remains a mainstay of melasma treatment, Dr. Pandya said. "Hydroquinone remains the most effective depigmentation agent." There are nine marketed products that contain hydroquinone 4%. Although higher concentrations might be more effective, skin irritation and tolerance become an important consideration.

Monitor patients for development of exogenous ochronosis, a rare but important adverse effect, Dr. Pandya advised. Also, some patients can develop telangiectasias after prolonged use.

Hydroquinone 4% is often found in combination products designed to balance efficacy and tolerability. For example, Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma) is a triple combination product that was "shown to be better than any two components in the largest study done so far in melasma," Dr. Pandya said (Cutis 2003;72:67-72). Researchers in this study found a 75% reduction in melasma at 8 weeks in more than 70% of patients, compared with 30% of participants treated with a dual-ingredient product.

A majority "seem to do well, but the problem is irritation, especially in skin of color," Dr. Pandya said. "I usually start patients on this product every other day and then try to increase it, but in some cases, I cannot because of irritation." He emphasized the importance of monitoring patients closely to ensure they do not develop erythema or postinflammatory hypopigmentation.

Evidence on the efficacy of chemical peels in treating melasma is mixed, Dr. Pandya said. In one study of 40 women in India, glycolic acid and a modified Kligman's formula peel showed "some improvement, but it took six glycolic acid peels," Dr. Pandya said (Derm. Surg. 2002;28:828-32).

In his own study, Dr. Pandya and his associates compared a glycolic acid peel and hydroquinone to hydroquinone treatment alone in a split-face study of 21 women (Arch. Dermatol. 2002;138:1578-82). "The peel did not make a difference versus the side of face treated with hydroquinone only," Dr. Pandya said.

Although there are no published studies supporting or not supporting microdermabrasion in melasma, caution is advised when this approach is used, Dr. Pandya said. "If you are too aggressive, you can induce hyperpigmentation."

One of the biggest challenges for dermatologists may be convincing patients of the importance of using sunscreen for UV protection, not only while outside but if they remain indoors as well. "Visible light can also induce melanocyte formation, not just UVA or UVB," Dr. Pandya said. "That's bad news, because how many companies at this convention center will have a product that says 'This blocks visible light?’ The only thing we have is the thick stuff lifeguards put on their noses."

Dr. Pandya said, "Frequent application of broad spectrum and physical sunscreens, as well as avoidance of UV and visible light, are critical for long-term success."

Dr. Pandya said that he is a consultant for Galderma.

WASHINGTON – Breakthroughs in human genetics combined with funding from the Affordable Care Act have poised the National Institutes of Health to make real progress in the areas of orphan human diseases, according to NIH Director Francis S. Collins.

Speaking with enthusiasm to those he addressed as his "peeps" at the annual meeting of the American Society of Human Genetics, Dr. Collins shared his excitement at the state of human genetics in the post-genomic world, in large part driven by technology that has significantly lowered the cost of DNA sequencing, in turn speeding genetic research tremendously.

This, combined with new ACA funding, has enabled NIH to fund and pursue translational research, moving laboratory results toward and into clinical trials, something that is a new way of thinking for the agency, Dr. Collins said.

Rather than relying on pharmaceutical and biotechnology companies to take charge of the translational research, Dr. Collins encouraged academic researchers to consider partnering with NIH, at least for those orphan disease conditions in which the federal government would not be seen as being in competition with private enterprise.

"There is a serious crisis underway in the way in which this pipeline for drug discovery has been floundering. ... Pharma has been investing a larger and larger amount of money – between $40 and $50 billion dollars a year – and yet in spite of that, FDA approvals of new molecular entities, that is genuinely new drug therapeutics, not ‘me-toos,’ have been dropping steadily over the last 15 years," Dr. Collins said.

The reasons for this are complex, he said, but a big part of the problem involves coming up with appropriate targets and targeting compounds. He said this is an area in which NIH is and can be very much involved.

NIH now encourages academic researchers to take their targets to the assay stage and beyond, providing high-throughput screening (HTS) assistance from the NIH Chemical Genomics Center. Subsequent medicinal chemistry assistance is also available to help to modify HTS hits to enable compounds to become more drug-like and to match current ADME (absorption, distribution, metabolism, and excretion) criteria.

With NIH assistance, more than 150 lead compounds have reached this stage over the last 4-5 years, more than half of which are "poised to go to the next step" of preclinical trials in animals, or the "Valley of Death," according to Dr. Collins, "because this is where projects often go to die."

NIH is now able to assist in this high-risk area through the Therapeutics for Rare and Neglected Diseases (TRND) program in its Office of Rare Diseases Research. The TRND was funded at $24 million in fiscal year 2009.

NIH also is positioned to assist researchers in early phase human trials of orphan diseases through its 240-bed Clinical Center, Dr. Collins said.

"And we have 50 and soon we will have 60 Clinical and Translational Science Awards scattered all across the country which will also be set up to conduct these sorts of trials for new molecular entities," he added.

This new direction in research funding has involved unprecedented cooperation with the Food and Drug Administration, Dr. Collins said, with an NIH-FDA leadership council formed to ensure that new drug candidates are most safely and efficiently moved into the clinical trials framework in ways that would best enable FDA analysis and validation, particularly for rare diseases.

Dr. Collins was particularly excited about five instances in which NIH is using this new model of helping "de-risk" the drug development process for orphan or neglected diseases through TRND. These include four rare diseases (Niemann-Pick Disease Type C, hereditary inclusion body myopathy, sickle cell disease, and chronic lymphocytic leukemia) and one neglected disease (schistosomiasis).

If and when these compounds and those for other rare diseases become ready for marketing and production, NIH would then work with private companies to achieve licensing agreement to enable their manufacture and sale, according to Dr. Collins.

Dr. Collins reported having no financial conflicts of interest with regard to his presentation.

WASHINGTON – Breakthroughs in human genetics combined with funding from the Affordable Care Act have poised the National Institutes of Health to make real progress in the areas of orphan human diseases, according to NIH Director Francis S. Collins.

Speaking with enthusiasm to those he addressed as his "peeps" at the annual meeting of the American Society of Human Genetics, Dr. Collins shared his excitement at the state of human genetics in the post-genomic world, in large part driven by technology that has significantly lowered the cost of DNA sequencing, in turn speeding genetic research tremendously.

This, combined with new ACA funding, has enabled NIH to fund and pursue translational research, moving laboratory results toward and into clinical trials, something that is a new way of thinking for the agency, Dr. Collins said.

Rather than relying on pharmaceutical and biotechnology companies to take charge of the translational research, Dr. Collins encouraged academic researchers to consider partnering with NIH, at least for those orphan disease conditions in which the federal government would not be seen as being in competition with private enterprise.

"There is a serious crisis underway in the way in which this pipeline for drug discovery has been floundering. ... Pharma has been investing a larger and larger amount of money – between $40 and $50 billion dollars a year – and yet in spite of that, FDA approvals of new molecular entities, that is genuinely new drug therapeutics, not ‘me-toos,’ have been dropping steadily over the last 15 years," Dr. Collins said.

The reasons for this are complex, he said, but a big part of the problem involves coming up with appropriate targets and targeting compounds. He said this is an area in which NIH is and can be very much involved.

NIH now encourages academic researchers to take their targets to the assay stage and beyond, providing high-throughput screening (HTS) assistance from the NIH Chemical Genomics Center. Subsequent medicinal chemistry assistance is also available to help to modify HTS hits to enable compounds to become more drug-like and to match current ADME (absorption, distribution, metabolism, and excretion) criteria.

With NIH assistance, more than 150 lead compounds have reached this stage over the last 4-5 years, more than half of which are "poised to go to the next step" of preclinical trials in animals, or the "Valley of Death," according to Dr. Collins, "because this is where projects often go to die."

NIH is now able to assist in this high-risk area through the Therapeutics for Rare and Neglected Diseases (TRND) program in its Office of Rare Diseases Research. The TRND was funded at $24 million in fiscal year 2009.

NIH also is positioned to assist researchers in early phase human trials of orphan diseases through its 240-bed Clinical Center, Dr. Collins said.

"And we have 50 and soon we will have 60 Clinical and Translational Science Awards scattered all across the country which will also be set up to conduct these sorts of trials for new molecular entities," he added.

This new direction in research funding has involved unprecedented cooperation with the Food and Drug Administration, Dr. Collins said, with an NIH-FDA leadership council formed to ensure that new drug candidates are most safely and efficiently moved into the clinical trials framework in ways that would best enable FDA analysis and validation, particularly for rare diseases.

Dr. Collins was particularly excited about five instances in which NIH is using this new model of helping "de-risk" the drug development process for orphan or neglected diseases through TRND. These include four rare diseases (Niemann-Pick Disease Type C, hereditary inclusion body myopathy, sickle cell disease, and chronic lymphocytic leukemia) and one neglected disease (schistosomiasis).

If and when these compounds and those for other rare diseases become ready for marketing and production, NIH would then work with private companies to achieve licensing agreement to enable their manufacture and sale, according to Dr. Collins.

Dr. Collins reported having no financial conflicts of interest with regard to his presentation.

WASHINGTON – Breakthroughs in human genetics combined with funding from the Affordable Care Act have poised the National Institutes of Health to make real progress in the areas of orphan human diseases, according to NIH Director Francis S. Collins.

Speaking with enthusiasm to those he addressed as his "peeps" at the annual meeting of the American Society of Human Genetics, Dr. Collins shared his excitement at the state of human genetics in the post-genomic world, in large part driven by technology that has significantly lowered the cost of DNA sequencing, in turn speeding genetic research tremendously.

This, combined with new ACA funding, has enabled NIH to fund and pursue translational research, moving laboratory results toward and into clinical trials, something that is a new way of thinking for the agency, Dr. Collins said.

Rather than relying on pharmaceutical and biotechnology companies to take charge of the translational research, Dr. Collins encouraged academic researchers to consider partnering with NIH, at least for those orphan disease conditions in which the federal government would not be seen as being in competition with private enterprise.

"There is a serious crisis underway in the way in which this pipeline for drug discovery has been floundering. ... Pharma has been investing a larger and larger amount of money – between $40 and $50 billion dollars a year – and yet in spite of that, FDA approvals of new molecular entities, that is genuinely new drug therapeutics, not ‘me-toos,’ have been dropping steadily over the last 15 years," Dr. Collins said.

The reasons for this are complex, he said, but a big part of the problem involves coming up with appropriate targets and targeting compounds. He said this is an area in which NIH is and can be very much involved.

NIH now encourages academic researchers to take their targets to the assay stage and beyond, providing high-throughput screening (HTS) assistance from the NIH Chemical Genomics Center. Subsequent medicinal chemistry assistance is also available to help to modify HTS hits to enable compounds to become more drug-like and to match current ADME (absorption, distribution, metabolism, and excretion) criteria.

With NIH assistance, more than 150 lead compounds have reached this stage over the last 4-5 years, more than half of which are "poised to go to the next step" of preclinical trials in animals, or the "Valley of Death," according to Dr. Collins, "because this is where projects often go to die."

NIH is now able to assist in this high-risk area through the Therapeutics for Rare and Neglected Diseases (TRND) program in its Office of Rare Diseases Research. The TRND was funded at $24 million in fiscal year 2009.

NIH also is positioned to assist researchers in early phase human trials of orphan diseases through its 240-bed Clinical Center, Dr. Collins said.

"And we have 50 and soon we will have 60 Clinical and Translational Science Awards scattered all across the country which will also be set up to conduct these sorts of trials for new molecular entities," he added.

This new direction in research funding has involved unprecedented cooperation with the Food and Drug Administration, Dr. Collins said, with an NIH-FDA leadership council formed to ensure that new drug candidates are most safely and efficiently moved into the clinical trials framework in ways that would best enable FDA analysis and validation, particularly for rare diseases.

Dr. Collins was particularly excited about five instances in which NIH is using this new model of helping "de-risk" the drug development process for orphan or neglected diseases through TRND. These include four rare diseases (Niemann-Pick Disease Type C, hereditary inclusion body myopathy, sickle cell disease, and chronic lymphocytic leukemia) and one neglected disease (schistosomiasis).

If and when these compounds and those for other rare diseases become ready for marketing and production, NIH would then work with private companies to achieve licensing agreement to enable their manufacture and sale, according to Dr. Collins.

Dr. Collins reported having no financial conflicts of interest with regard to his presentation.

Pigmentary disorders are more than just a cosmetic concern, according to Dr. Susan C. Taylor.

Studies show that disorders such as melasma and post-inflammatory hyperpigmentation (PIH) are particularly common in women with darker skin, and the conditions can have a profound effect on quality of life, Dr. Taylor said at the Las Vegas Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

In one prospective cohort study, 47% of patients with pigmentation disorders said they felt self-conscious about their skin, 33% reported feeling unattractive, and 33% reported putting effort into hiding pigment changes. Nearly 24% said they thought their skin condition affected their activities, and 22% believed others focused on their skin (J. Cosmet. Dermatol. 2008;7:164-8).

"These conditions should be treated aggressively," said Dr. Taylor, founding director of the Skin of Color Center at St. Luke's–Roosevelt Hospital Center in New York. For both melasma and PIH, that means using treatments that decrease melanin formation, block the transfer of melanosomes, minimize inflammation, and nonselectively suppress melanogenesis, or increase melanin removal through desquamation, she said.

Photo credit: @2007 Elsevier Inc.

Dr. Taylor, who also is an assistant clinical professor of dermatology at Columbia University, New York, said topical therapies are not curative, but they can be effective.

For melasma, triple combination therapy with a cream containing hydroquinone (4%), retinoic acid (0.05%), and fluocinolone acetonide (0.01%) has been shown to be quite effective in multiple studies, and is Dr. Taylor’s preferred treatment.

Data from two 8-week randomized trials showed that significantly more patients treated with the triple combination cream experienced complete clearing, compared with patients treated with dyad creams (26% vs. 5%). An extension study showed that 80% of patients treated with, or switched to the triple-combination cream, were completely cleared or nearly cleared at 12 months. Only 2.5% of patients discontinued the study because of treatment-related adverse events (J. Drugs. Dermatol. 2005;4:592-7).

Other options shown to be of benefit for the topical treatment of melasma include 0.1% tretinoin cream or 20% azelaic acid cream, Dr. Taylor said.

Oral therapy with procyanidin plus vitamins A, C, and E also shows promise. In an 8-week randomized, double-blind, placebo-controlled trial in 60 Filipino women, treatment was associated with significant improvements in the left and right malar regions, and was safe and well tolerated (Int. J. Dermatol. 2009;48:896-901). However, additional studies are needed to confirm these results, she noted.

Chemical peeling agents can serve as good adjuncts to other therapies for melasma, particularly in recalcitrant cases. In one study, Dr. Taylor said, the addition of eight glycolic acid peels to topical therapy with azelaic acid and adapalene gel improved outcomes vs. the topical treatments alone. Priming agents such as 2% hydroquinone and 0.025% retinoic acid can boost the effects of such peels (J. Dermatol. 2007;34:25-30).

Finally, an emerging treatment option for melasma appears to be fractional photothermolysis.

In a pilot study, 10 female melasma patients who failed prior treatments received four to six fractional laser treatments at 1-2 week intervals using 1,535 nm and 1,550 nm wavelengths and 6-12 mJ/microthermal zone. Most patients (60%) had 75%-100% clearing, and 30% had less than 25% improvement, Dr. Taylor said (Dermatol. Surg. 2005;31:1645-50).

The investigators used microdermabrasion to improve penetration to the target site, followed by an effective tyrosinase inhibitor to suppress melanocytes and remove melanin from the stratum corneum, she explained, adding that sunscreens and topical vitamin C were also used.

"Fractional resurfacing may hold the key to treatment of dermal melasma," she said. It also appears to be useful in PIH.

A case report of its use in a patient with PIH on the neck that had failed to respond to topical therapies for 2 years showed that after 3 treatments, the patient had near-complete clearing with no post-procedural complications or recurrence at 7-month follow-up. Treatment was with a 1,550 nm wavelength erbium-doped Fraxel SR1500 laser at a fluence of 15 mJ, level of 6, with 8-10 passes (Dermatol. Surg. 2009;35:1844-8), Dr. Taylor said.

She cautioned, however, that using lasers in patients with skin of color can potentially cause PIH.

Other treatment options for PIH include hydroquinones, which remain the gold standard, and retinoids, mequinol, and azelaic acid, she said, noting that all patients with melasma and PIH should be advised to use sunblock, protective clothing, and sunglasses and to avoid ultraviolet exposure when possible.

Dr. Taylor serves on advisory boards for Beiersdorf, Johnson & Johnson, Medicis, and GlaxoSmithKline. She has been an investigator for Johnson & Johnson, Medicis, Merz, and Palomar, and is on the speakers bureau of Medicis and Stiefel. She owns stock in T2 Skincare.

SDEF and this news organization are owned by Elsevier.

Pigmentary disorders are more than just a cosmetic concern, according to Dr. Susan C. Taylor.

Studies show that disorders such as melasma and post-inflammatory hyperpigmentation (PIH) are particularly common in women with darker skin, and the conditions can have a profound effect on quality of life, Dr. Taylor said at the Las Vegas Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

In one prospective cohort study, 47% of patients with pigmentation disorders said they felt self-conscious about their skin, 33% reported feeling unattractive, and 33% reported putting effort into hiding pigment changes. Nearly 24% said they thought their skin condition affected their activities, and 22% believed others focused on their skin (J. Cosmet. Dermatol. 2008;7:164-8).

"These conditions should be treated aggressively," said Dr. Taylor, founding director of the Skin of Color Center at St. Luke's–Roosevelt Hospital Center in New York. For both melasma and PIH, that means using treatments that decrease melanin formation, block the transfer of melanosomes, minimize inflammation, and nonselectively suppress melanogenesis, or increase melanin removal through desquamation, she said.

Photo credit: @2007 Elsevier Inc.

Dr. Taylor, who also is an assistant clinical professor of dermatology at Columbia University, New York, said topical therapies are not curative, but they can be effective.

For melasma, triple combination therapy with a cream containing hydroquinone (4%), retinoic acid (0.05%), and fluocinolone acetonide (0.01%) has been shown to be quite effective in multiple studies, and is Dr. Taylor’s preferred treatment.

Data from two 8-week randomized trials showed that significantly more patients treated with the triple combination cream experienced complete clearing, compared with patients treated with dyad creams (26% vs. 5%). An extension study showed that 80% of patients treated with, or switched to the triple-combination cream, were completely cleared or nearly cleared at 12 months. Only 2.5% of patients discontinued the study because of treatment-related adverse events (J. Drugs. Dermatol. 2005;4:592-7).

Other options shown to be of benefit for the topical treatment of melasma include 0.1% tretinoin cream or 20% azelaic acid cream, Dr. Taylor said.

Oral therapy with procyanidin plus vitamins A, C, and E also shows promise. In an 8-week randomized, double-blind, placebo-controlled trial in 60 Filipino women, treatment was associated with significant improvements in the left and right malar regions, and was safe and well tolerated (Int. J. Dermatol. 2009;48:896-901). However, additional studies are needed to confirm these results, she noted.

Chemical peeling agents can serve as good adjuncts to other therapies for melasma, particularly in recalcitrant cases. In one study, Dr. Taylor said, the addition of eight glycolic acid peels to topical therapy with azelaic acid and adapalene gel improved outcomes vs. the topical treatments alone. Priming agents such as 2% hydroquinone and 0.025% retinoic acid can boost the effects of such peels (J. Dermatol. 2007;34:25-30).

Finally, an emerging treatment option for melasma appears to be fractional photothermolysis.

In a pilot study, 10 female melasma patients who failed prior treatments received four to six fractional laser treatments at 1-2 week intervals using 1,535 nm and 1,550 nm wavelengths and 6-12 mJ/microthermal zone. Most patients (60%) had 75%-100% clearing, and 30% had less than 25% improvement, Dr. Taylor said (Dermatol. Surg. 2005;31:1645-50).

The investigators used microdermabrasion to improve penetration to the target site, followed by an effective tyrosinase inhibitor to suppress melanocytes and remove melanin from the stratum corneum, she explained, adding that sunscreens and topical vitamin C were also used.

"Fractional resurfacing may hold the key to treatment of dermal melasma," she said. It also appears to be useful in PIH.

A case report of its use in a patient with PIH on the neck that had failed to respond to topical therapies for 2 years showed that after 3 treatments, the patient had near-complete clearing with no post-procedural complications or recurrence at 7-month follow-up. Treatment was with a 1,550 nm wavelength erbium-doped Fraxel SR1500 laser at a fluence of 15 mJ, level of 6, with 8-10 passes (Dermatol. Surg. 2009;35:1844-8), Dr. Taylor said.

She cautioned, however, that using lasers in patients with skin of color can potentially cause PIH.

Other treatment options for PIH include hydroquinones, which remain the gold standard, and retinoids, mequinol, and azelaic acid, she said, noting that all patients with melasma and PIH should be advised to use sunblock, protective clothing, and sunglasses and to avoid ultraviolet exposure when possible.

Dr. Taylor serves on advisory boards for Beiersdorf, Johnson & Johnson, Medicis, and GlaxoSmithKline. She has been an investigator for Johnson & Johnson, Medicis, Merz, and Palomar, and is on the speakers bureau of Medicis and Stiefel. She owns stock in T2 Skincare.

SDEF and this news organization are owned by Elsevier.

Pigmentary disorders are more than just a cosmetic concern, according to Dr. Susan C. Taylor.

Studies show that disorders such as melasma and post-inflammatory hyperpigmentation (PIH) are particularly common in women with darker skin, and the conditions can have a profound effect on quality of life, Dr. Taylor said at the Las Vegas Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

In one prospective cohort study, 47% of patients with pigmentation disorders said they felt self-conscious about their skin, 33% reported feeling unattractive, and 33% reported putting effort into hiding pigment changes. Nearly 24% said they thought their skin condition affected their activities, and 22% believed others focused on their skin (J. Cosmet. Dermatol. 2008;7:164-8).

"These conditions should be treated aggressively," said Dr. Taylor, founding director of the Skin of Color Center at St. Luke's–Roosevelt Hospital Center in New York. For both melasma and PIH, that means using treatments that decrease melanin formation, block the transfer of melanosomes, minimize inflammation, and nonselectively suppress melanogenesis, or increase melanin removal through desquamation, she said.

Photo credit: @2007 Elsevier Inc.

Dr. Taylor, who also is an assistant clinical professor of dermatology at Columbia University, New York, said topical therapies are not curative, but they can be effective.

For melasma, triple combination therapy with a cream containing hydroquinone (4%), retinoic acid (0.05%), and fluocinolone acetonide (0.01%) has been shown to be quite effective in multiple studies, and is Dr. Taylor’s preferred treatment.

Data from two 8-week randomized trials showed that significantly more patients treated with the triple combination cream experienced complete clearing, compared with patients treated with dyad creams (26% vs. 5%). An extension study showed that 80% of patients treated with, or switched to the triple-combination cream, were completely cleared or nearly cleared at 12 months. Only 2.5% of patients discontinued the study because of treatment-related adverse events (J. Drugs. Dermatol. 2005;4:592-7).

Other options shown to be of benefit for the topical treatment of melasma include 0.1% tretinoin cream or 20% azelaic acid cream, Dr. Taylor said.

Oral therapy with procyanidin plus vitamins A, C, and E also shows promise. In an 8-week randomized, double-blind, placebo-controlled trial in 60 Filipino women, treatment was associated with significant improvements in the left and right malar regions, and was safe and well tolerated (Int. J. Dermatol. 2009;48:896-901). However, additional studies are needed to confirm these results, she noted.

Chemical peeling agents can serve as good adjuncts to other therapies for melasma, particularly in recalcitrant cases. In one study, Dr. Taylor said, the addition of eight glycolic acid peels to topical therapy with azelaic acid and adapalene gel improved outcomes vs. the topical treatments alone. Priming agents such as 2% hydroquinone and 0.025% retinoic acid can boost the effects of such peels (J. Dermatol. 2007;34:25-30).

Finally, an emerging treatment option for melasma appears to be fractional photothermolysis.

In a pilot study, 10 female melasma patients who failed prior treatments received four to six fractional laser treatments at 1-2 week intervals using 1,535 nm and 1,550 nm wavelengths and 6-12 mJ/microthermal zone. Most patients (60%) had 75%-100% clearing, and 30% had less than 25% improvement, Dr. Taylor said (Dermatol. Surg. 2005;31:1645-50).

The investigators used microdermabrasion to improve penetration to the target site, followed by an effective tyrosinase inhibitor to suppress melanocytes and remove melanin from the stratum corneum, she explained, adding that sunscreens and topical vitamin C were also used.

"Fractional resurfacing may hold the key to treatment of dermal melasma," she said. It also appears to be useful in PIH.

A case report of its use in a patient with PIH on the neck that had failed to respond to topical therapies for 2 years showed that after 3 treatments, the patient had near-complete clearing with no post-procedural complications or recurrence at 7-month follow-up. Treatment was with a 1,550 nm wavelength erbium-doped Fraxel SR1500 laser at a fluence of 15 mJ, level of 6, with 8-10 passes (Dermatol. Surg. 2009;35:1844-8), Dr. Taylor said.

She cautioned, however, that using lasers in patients with skin of color can potentially cause PIH.

Other treatment options for PIH include hydroquinones, which remain the gold standard, and retinoids, mequinol, and azelaic acid, she said, noting that all patients with melasma and PIH should be advised to use sunblock, protective clothing, and sunglasses and to avoid ultraviolet exposure when possible.

Dr. Taylor serves on advisory boards for Beiersdorf, Johnson & Johnson, Medicis, and GlaxoSmithKline. She has been an investigator for Johnson & Johnson, Medicis, Merz, and Palomar, and is on the speakers bureau of Medicis and Stiefel. She owns stock in T2 Skincare.

SDEF and this news organization are owned by Elsevier.