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Alternating Clobetasol, Ketoconazole Shampoos Can Treat Seborrheic Dermatitis

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Alternating Clobetasol, Ketoconazole Shampoos Can Treat Seborrheic Dermatitis

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

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SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

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Alternating Clobetasol, Ketoconazole Shampoos Can Treat Seborrheic Dermatitis
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Major Finding: By week 8, efficacy was sustained throughout the maintenance phase of 4 weeks of ketoconazole shampoo in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole shampoo twice weekly. In contrast, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores as well as measures of erythema, scaling, and itch.

Data Source: A 22-center, 12-week study conducted in Europe, North America, and Asia included 326 patients with moderate to severe scalp seborrheic dermatitis treated with various regimens of clobetasol and ketoconazole shampoos.

Disclosures: Dr. Ortonne is a consultant to Galderma, the study sponsor.

Women Prefer 5% Minoxidil Foam for Alopecia

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SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm2 or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

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SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm2 or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm2 or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

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FROM THE WORLD CONGRESS OF DERMATOLOGY

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Major Finding: Sixteen percent of women using once-daily 5% minoxidil foam reported significant pruritus, compared with 39% of women on 2% minoxidil solution.

Data Source: A 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss.

Disclosures: Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

Ciliary Madarosis in the Pediatric Population: A Case Report and Review of the Literature

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ciliary madarosis, CM, alopecia areata, AA, tinea capitis, trichotillomania, TTM, telogen effluvium, TE, biamtoprost ophthalmic solution, loss of eyelashes, pediatric alopecia, scarring alopecia, nonscarring alopecia, ichthyosis, patchy hair loss, thyroid mass, vitiligo, scaling, nail pits, hair bulbs, seratonin reuptake inhibitors, N-acetylcysteine, minoxidil, calcineurin inhibitors, griseofulvin, tramacinolone acetonide, cataract, glaucoma, calcineurin inhibitorsPezhman Shoureshi, Jenifer R. Lloyd, Latisse, Allergan, ciliary madarosis, CM, alopecia areata, AA, tinea capitis, trichotillomania, TTM, telogen effluvium, TE, biamtoprost ophthalmic solution, loss of eyelashes, pediatric alopecia, scarring alopecia, nonscarring alopecia, ichthyosis, patchy hair loss, thyroid mass, vitiligo, scaling, nail pits, hair bulbs, seratonin reuptake inhibitors, N-acetylcysteine, minoxidil, calcineurin inhibitors, griseofulvin, tramacinolone acetonide, cataract, glaucoma, calcineurin inhibitors
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Ciliary Madarosis in the Pediatric Population: A Case Report and Review of the Literature
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ciliary madarosis, CM, alopecia areata, AA, tinea capitis, trichotillomania, TTM, telogen effluvium, TE, biamtoprost ophthalmic solution, loss of eyelashes, pediatric alopecia, scarring alopecia, nonscarring alopecia, ichthyosis, patchy hair loss, thyroid mass, vitiligo, scaling, nail pits, hair bulbs, seratonin reuptake inhibitors, N-acetylcysteine, minoxidil, calcineurin inhibitors, griseofulvin, tramacinolone acetonide, cataract, glaucoma, calcineurin inhibitorsPezhman Shoureshi, Jenifer R. Lloyd, Latisse, Allergan, ciliary madarosis, CM, alopecia areata, AA, tinea capitis, trichotillomania, TTM, telogen effluvium, TE, biamtoprost ophthalmic solution, loss of eyelashes, pediatric alopecia, scarring alopecia, nonscarring alopecia, ichthyosis, patchy hair loss, thyroid mass, vitiligo, scaling, nail pits, hair bulbs, seratonin reuptake inhibitors, N-acetylcysteine, minoxidil, calcineurin inhibitors, griseofulvin, tramacinolone acetonide, cataract, glaucoma, calcineurin inhibitors
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ciliary madarosis, CM, alopecia areata, AA, tinea capitis, trichotillomania, TTM, telogen effluvium, TE, biamtoprost ophthalmic solution, loss of eyelashes, pediatric alopecia, scarring alopecia, nonscarring alopecia, ichthyosis, patchy hair loss, thyroid mass, vitiligo, scaling, nail pits, hair bulbs, seratonin reuptake inhibitors, N-acetylcysteine, minoxidil, calcineurin inhibitors, griseofulvin, tramacinolone acetonide, cataract, glaucoma, calcineurin inhibitorsPezhman Shoureshi, Jenifer R. Lloyd, Latisse, Allergan, ciliary madarosis, CM, alopecia areata, AA, tinea capitis, trichotillomania, TTM, telogen effluvium, TE, biamtoprost ophthalmic solution, loss of eyelashes, pediatric alopecia, scarring alopecia, nonscarring alopecia, ichthyosis, patchy hair loss, thyroid mass, vitiligo, scaling, nail pits, hair bulbs, seratonin reuptake inhibitors, N-acetylcysteine, minoxidil, calcineurin inhibitors, griseofulvin, tramacinolone acetonide, cataract, glaucoma, calcineurin inhibitors
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Hair Care Practices in Black Women With and Without Scarring Alopecia: A Retrospective Cohort Study

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Hair Care Practices in Black Women With and Without Scarring Alopecia: A Retrospective Cohort Study

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black women, alopecia, hair care, scarring alopecia, hair loss, chemical relaxers, hairpieces, braids, hair dye, hair spray, hair gel, hot comb, chemical curling agents, lupus, thyroid disease, rheumatoid arthritis, ulcerative colitis, Crohn disease, diabetes mellitus, keloid scars, hair weaves, frontal area of the scalp, vertex area of the scalp, pain, itching, scaling, papules, pustules, folliculosbaceous units, perifollicular hyperplasia, fibroplasia, fibrosis, onion skin, mononuclear inflammation, perifollicular lymphocytic infiltrate, central centrifugal cicatricial alopecia, CCCAAmy J. McMichael, Ingrid Freeney, Williette Robertson, Robert Henderson, Reem Utterback, Kemery Gilbert, black women, alopecia, hair care, scarring alopecia, hair loss, chemical relaxers, hairpieces, braids, hair dye, hair spray, hair gel, hot comb, chemical curling agents, lupus, thyroid disease, rheumatoid arthritis, ulcerative colitis, Crohn disease, diabetes mellitus, keloid scars, hair weaves, frontal area of the scalp, vertex area of the scalp, pain, itching, scaling, papules, pustules, folliculosbaceous units, perifollicular hyperplasia, fibroplasia, fibrosis, onion skin, mononuclear inflammation, perifollicular lymphocytic infiltrate, central centrifugal cicatricial alopecia, CCCA
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Hair Care Practices in Black Women With and Without Scarring Alopecia: A Retrospective Cohort Study
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black women, alopecia, hair care, scarring alopecia, hair loss, chemical relaxers, hairpieces, braids, hair dye, hair spray, hair gel, hot comb, chemical curling agents, lupus, thyroid disease, rheumatoid arthritis, ulcerative colitis, Crohn disease, diabetes mellitus, keloid scars, hair weaves, frontal area of the scalp, vertex area of the scalp, pain, itching, scaling, papules, pustules, folliculosbaceous units, perifollicular hyperplasia, fibroplasia, fibrosis, onion skin, mononuclear inflammation, perifollicular lymphocytic infiltrate, central centrifugal cicatricial alopecia, CCCAAmy J. McMichael, Ingrid Freeney, Williette Robertson, Robert Henderson, Reem Utterback, Kemery Gilbert, black women, alopecia, hair care, scarring alopecia, hair loss, chemical relaxers, hairpieces, braids, hair dye, hair spray, hair gel, hot comb, chemical curling agents, lupus, thyroid disease, rheumatoid arthritis, ulcerative colitis, Crohn disease, diabetes mellitus, keloid scars, hair weaves, frontal area of the scalp, vertex area of the scalp, pain, itching, scaling, papules, pustules, folliculosbaceous units, perifollicular hyperplasia, fibroplasia, fibrosis, onion skin, mononuclear inflammation, perifollicular lymphocytic infiltrate, central centrifugal cicatricial alopecia, CCCA
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black women, alopecia, hair care, scarring alopecia, hair loss, chemical relaxers, hairpieces, braids, hair dye, hair spray, hair gel, hot comb, chemical curling agents, lupus, thyroid disease, rheumatoid arthritis, ulcerative colitis, Crohn disease, diabetes mellitus, keloid scars, hair weaves, frontal area of the scalp, vertex area of the scalp, pain, itching, scaling, papules, pustules, folliculosbaceous units, perifollicular hyperplasia, fibroplasia, fibrosis, onion skin, mononuclear inflammation, perifollicular lymphocytic infiltrate, central centrifugal cicatricial alopecia, CCCAAmy J. McMichael, Ingrid Freeney, Williette Robertson, Robert Henderson, Reem Utterback, Kemery Gilbert, black women, alopecia, hair care, scarring alopecia, hair loss, chemical relaxers, hairpieces, braids, hair dye, hair spray, hair gel, hot comb, chemical curling agents, lupus, thyroid disease, rheumatoid arthritis, ulcerative colitis, Crohn disease, diabetes mellitus, keloid scars, hair weaves, frontal area of the scalp, vertex area of the scalp, pain, itching, scaling, papules, pustules, folliculosbaceous units, perifollicular hyperplasia, fibroplasia, fibrosis, onion skin, mononuclear inflammation, perifollicular lymphocytic infiltrate, central centrifugal cicatricial alopecia, CCCA
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FDA: Prostate Cancer Warning Added to BPH Drug Labels

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Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

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Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

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Scrubbing Often During Nail Removal Reduces Infection Rates

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LAS VEGAS – Preoperative scrubs before nail avulsion fail to reduce postoperative infection, recent data suggest.

However, studies have identified best practices for reducing bacterial counts – such as irrigating after nail plate avulsion though there is no evidence that the measures reduce postoperative infection rates.

Photo credit: Dr. Nathaniel J. Jellinek
A methicillin-sensitive Staphylococcus aureus infection of the nail is shown.     

"Every study that has looked at rates of colonization or recolonization after your scrub showed significant bacterial presence. As good as our scrubs are, they're probably not good enough," Dr. Nathaniel J. Jellinek said at the annual meeting of the American College of Mohs Surgery.

A recent study measured bacterial counts after a 7-minute surgical scrub and again after avulsion of the nail plate. The bacterial counts were essentially the same. "It's as if the surgical scrub didn't do any good," said Dr. Jellinek, who was not involved in the study (Dermatol. Surg. 2010;36:1258-65).

The investigators then irrigated the nail bed with saline, which reduced bacterial counts by 95%. That's "an easy thing to do intraoperatively that you might consider for your practice," said Dr. Jellinek of the department of dermatology at Brown University, Providence, R.I.

Studies published mainly in the podiatric and orthopedic literature show that postoperative infection rates are higher after nail surgery than after skin surgery. Rates of bacterial colonization before and after surgical preparation of nails make the term "sterile surgery" inaccurate for these procedures, which might better be considered clean-contaminated or even contaminated surgery, he said in an interview after his presentation.

Photo credit: Dr. Nathaniel J. Jellinek
A fingernail with a Pseudomonas aeruginosa infection can be seen.    

Other studies have shown that applying alcohol and chlorhexidine may be superior to chloroxylenol and povidone-iodine to reduce bacterial counts before nail surgery. Bacterial persistence and recolonization also can be reduced by the use of bristled brushes, soaked gauze pads, scrubbing to the interdigital webs, and repeat scrubs.

"At this point, it's all hypothetical whether it decreases infection. But we know that infection rates are unacceptably high, so it can only help if you decrease the bacterial count," Dr. Jellinek said.

He has added multiple prophylactic measures to his practice, where he performs a lot of nail surgery.

First, Dr. Jellinek informs the patient that the nail is a dirty site, he reviews wound care, and educates the patient to pay attention to risk factors for infection and avoid putting fingers or toes in dirty places.

He recommends strict sterile preoperative and intraoperative techniques. A nurse or medical assistant should scrub the surgical area for several minutes. "We're talking not 10 or 30 seconds, but 2, 3, 5 minutes," he said.

The scrub should use multiple agents. He prefers using a bristle brush to scrub with chlorhexidine, gauze pads soaked in 70% isopropyl alcohol, and maybe even povidone-iodine paint. He lets all that sit, and applies a sterile glove over the digit, hand, or foot after the scrub.

During surgery, once the nail plate is avulsed, he recommends either performing a repeat scrub or at least irrigating the nail bed with sterile saline.

Dr. Jellinek said recent data have lowered his threshold for using prophylactic antibiotics. He has come to appreciate that nail infections may be caused by different organisms than those that cause most skin infections and require different antibiotics for treatment.

As a result, "I actually have very few nail infections, but I can't pinpoint which of those five or six things that I've done give me those results," he said.

Studies of prophylactic measures to avoid postoperative nail infections include:

Dr. Jellinek said he had no relevant financial disclosures.

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LAS VEGAS – Preoperative scrubs before nail avulsion fail to reduce postoperative infection, recent data suggest.

However, studies have identified best practices for reducing bacterial counts – such as irrigating after nail plate avulsion though there is no evidence that the measures reduce postoperative infection rates.

Photo credit: Dr. Nathaniel J. Jellinek
A methicillin-sensitive Staphylococcus aureus infection of the nail is shown.     

"Every study that has looked at rates of colonization or recolonization after your scrub showed significant bacterial presence. As good as our scrubs are, they're probably not good enough," Dr. Nathaniel J. Jellinek said at the annual meeting of the American College of Mohs Surgery.

A recent study measured bacterial counts after a 7-minute surgical scrub and again after avulsion of the nail plate. The bacterial counts were essentially the same. "It's as if the surgical scrub didn't do any good," said Dr. Jellinek, who was not involved in the study (Dermatol. Surg. 2010;36:1258-65).

The investigators then irrigated the nail bed with saline, which reduced bacterial counts by 95%. That's "an easy thing to do intraoperatively that you might consider for your practice," said Dr. Jellinek of the department of dermatology at Brown University, Providence, R.I.

Studies published mainly in the podiatric and orthopedic literature show that postoperative infection rates are higher after nail surgery than after skin surgery. Rates of bacterial colonization before and after surgical preparation of nails make the term "sterile surgery" inaccurate for these procedures, which might better be considered clean-contaminated or even contaminated surgery, he said in an interview after his presentation.

Photo credit: Dr. Nathaniel J. Jellinek
A fingernail with a Pseudomonas aeruginosa infection can be seen.    

Other studies have shown that applying alcohol and chlorhexidine may be superior to chloroxylenol and povidone-iodine to reduce bacterial counts before nail surgery. Bacterial persistence and recolonization also can be reduced by the use of bristled brushes, soaked gauze pads, scrubbing to the interdigital webs, and repeat scrubs.

"At this point, it's all hypothetical whether it decreases infection. But we know that infection rates are unacceptably high, so it can only help if you decrease the bacterial count," Dr. Jellinek said.

He has added multiple prophylactic measures to his practice, where he performs a lot of nail surgery.

First, Dr. Jellinek informs the patient that the nail is a dirty site, he reviews wound care, and educates the patient to pay attention to risk factors for infection and avoid putting fingers or toes in dirty places.

He recommends strict sterile preoperative and intraoperative techniques. A nurse or medical assistant should scrub the surgical area for several minutes. "We're talking not 10 or 30 seconds, but 2, 3, 5 minutes," he said.

The scrub should use multiple agents. He prefers using a bristle brush to scrub with chlorhexidine, gauze pads soaked in 70% isopropyl alcohol, and maybe even povidone-iodine paint. He lets all that sit, and applies a sterile glove over the digit, hand, or foot after the scrub.

During surgery, once the nail plate is avulsed, he recommends either performing a repeat scrub or at least irrigating the nail bed with sterile saline.

Dr. Jellinek said recent data have lowered his threshold for using prophylactic antibiotics. He has come to appreciate that nail infections may be caused by different organisms than those that cause most skin infections and require different antibiotics for treatment.

As a result, "I actually have very few nail infections, but I can't pinpoint which of those five or six things that I've done give me those results," he said.

Studies of prophylactic measures to avoid postoperative nail infections include:

Dr. Jellinek said he had no relevant financial disclosures.

LAS VEGAS – Preoperative scrubs before nail avulsion fail to reduce postoperative infection, recent data suggest.

However, studies have identified best practices for reducing bacterial counts – such as irrigating after nail plate avulsion though there is no evidence that the measures reduce postoperative infection rates.

Photo credit: Dr. Nathaniel J. Jellinek
A methicillin-sensitive Staphylococcus aureus infection of the nail is shown.     

"Every study that has looked at rates of colonization or recolonization after your scrub showed significant bacterial presence. As good as our scrubs are, they're probably not good enough," Dr. Nathaniel J. Jellinek said at the annual meeting of the American College of Mohs Surgery.

A recent study measured bacterial counts after a 7-minute surgical scrub and again after avulsion of the nail plate. The bacterial counts were essentially the same. "It's as if the surgical scrub didn't do any good," said Dr. Jellinek, who was not involved in the study (Dermatol. Surg. 2010;36:1258-65).

The investigators then irrigated the nail bed with saline, which reduced bacterial counts by 95%. That's "an easy thing to do intraoperatively that you might consider for your practice," said Dr. Jellinek of the department of dermatology at Brown University, Providence, R.I.

Studies published mainly in the podiatric and orthopedic literature show that postoperative infection rates are higher after nail surgery than after skin surgery. Rates of bacterial colonization before and after surgical preparation of nails make the term "sterile surgery" inaccurate for these procedures, which might better be considered clean-contaminated or even contaminated surgery, he said in an interview after his presentation.

Photo credit: Dr. Nathaniel J. Jellinek
A fingernail with a Pseudomonas aeruginosa infection can be seen.    

Other studies have shown that applying alcohol and chlorhexidine may be superior to chloroxylenol and povidone-iodine to reduce bacterial counts before nail surgery. Bacterial persistence and recolonization also can be reduced by the use of bristled brushes, soaked gauze pads, scrubbing to the interdigital webs, and repeat scrubs.

"At this point, it's all hypothetical whether it decreases infection. But we know that infection rates are unacceptably high, so it can only help if you decrease the bacterial count," Dr. Jellinek said.

He has added multiple prophylactic measures to his practice, where he performs a lot of nail surgery.

First, Dr. Jellinek informs the patient that the nail is a dirty site, he reviews wound care, and educates the patient to pay attention to risk factors for infection and avoid putting fingers or toes in dirty places.

He recommends strict sterile preoperative and intraoperative techniques. A nurse or medical assistant should scrub the surgical area for several minutes. "We're talking not 10 or 30 seconds, but 2, 3, 5 minutes," he said.

The scrub should use multiple agents. He prefers using a bristle brush to scrub with chlorhexidine, gauze pads soaked in 70% isopropyl alcohol, and maybe even povidone-iodine paint. He lets all that sit, and applies a sterile glove over the digit, hand, or foot after the scrub.

During surgery, once the nail plate is avulsed, he recommends either performing a repeat scrub or at least irrigating the nail bed with sterile saline.

Dr. Jellinek said recent data have lowered his threshold for using prophylactic antibiotics. He has come to appreciate that nail infections may be caused by different organisms than those that cause most skin infections and require different antibiotics for treatment.

As a result, "I actually have very few nail infections, but I can't pinpoint which of those five or six things that I've done give me those results," he said.

Studies of prophylactic measures to avoid postoperative nail infections include:

Dr. Jellinek said he had no relevant financial disclosures.

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EXPERT ANALYSIS FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF MOHS SURGERY

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Curing Acne: The Skinny Podcast

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In this month's episode reporters discuss a possible cure for acne based on research being conducted by Dr. R. Rox Anderson.

Photo credit: Naseem Miller
    Podcast anchors Carol Nicotera-Ward and Terry Rudd record this month's episode of The Skinny Podcast.

Dr. Albert C. Yan goes head to head with lice. He talks about a regimen that uses Cetaphil to suffocate the bugs.

Tips for reducing infection rates during nail surgery are given by Dr. Nathaniel Jellinek.

Dr. Lily Talakoub talks all things sunscreen.

And, last but not least, Dr. Alan Rockoff closes this month's episode with a story about a patient with very strong opinions, and he does a little singing too.

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In this month's episode reporters discuss a possible cure for acne based on research being conducted by Dr. R. Rox Anderson.

Photo credit: Naseem Miller
    Podcast anchors Carol Nicotera-Ward and Terry Rudd record this month's episode of The Skinny Podcast.

Dr. Albert C. Yan goes head to head with lice. He talks about a regimen that uses Cetaphil to suffocate the bugs.

Tips for reducing infection rates during nail surgery are given by Dr. Nathaniel Jellinek.

Dr. Lily Talakoub talks all things sunscreen.

And, last but not least, Dr. Alan Rockoff closes this month's episode with a story about a patient with very strong opinions, and he does a little singing too.

In this month's episode reporters discuss a possible cure for acne based on research being conducted by Dr. R. Rox Anderson.

Photo credit: Naseem Miller
    Podcast anchors Carol Nicotera-Ward and Terry Rudd record this month's episode of The Skinny Podcast.

Dr. Albert C. Yan goes head to head with lice. He talks about a regimen that uses Cetaphil to suffocate the bugs.

Tips for reducing infection rates during nail surgery are given by Dr. Nathaniel Jellinek.

Dr. Lily Talakoub talks all things sunscreen.

And, last but not least, Dr. Alan Rockoff closes this month's episode with a story about a patient with very strong opinions, and he does a little singing too.

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Ischemic Onycholysis of the Hands

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House Members Seek Recall of Formaldehyde-Containing Hair Straighteners

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House Members Seek Recall of Formaldehyde-Containing Hair Straighteners

Ten members of Congress have written to the Food and Drug Administration asking that the agency recall several brands of hair-straightening products that they say contain formaldehyde.

In a May 6 letter to FDA Commissioner Margaret Hamburg, U.S. House of Representative members wrote that the Brazilian Blowout Solution and Acai Professional Smoothing Solution both contain formaldehyde, but the chemical is not listed on the product labels as an ingredient.

Rep. Earl Blumenauer (D-Ore.) had written to the agency last fall outlining complaints from Oregon hair stylists who had been experiencing acute reactions, such as nosebleeds, while working with the hair straighteners. The congressman also noted testing conducted by the Oregon Occupational Safety and Health Division and by Oregon Health and Science University found the two products contained between 6% and 12% formaldehyde.

He said that the federal Occupational Safety and Health Administration (OSHA) subsequently issued a hazard alert warning salons to steer clear of formaldehyde-based straighteners.

Formaldehyde has been recognized as a possible carcinogen and has been the subject of 47 complaints to the Environmental Working Group, members of Congress noted in the letter.

"It is clear that the FDA needs to take decisive action," they wrote.

In addition to a recall, they are seeking a warning for products that contain formaldehyde, an investigation into the companies that are claiming their products are formaldehyde free, and a review of whether the chemical should be banned from hair straighteners.

According to the May 6 letter to Dr. Hamburg, the FDA responded in late November to Rep. Blumenauer's initial letter and said that it was investigating whether the products were being marketed directly to consumers. "If so, failure to comply with the ingredient declaration requirement would constitute misbranding," responded the agency.

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Ten members of Congress have written to the Food and Drug Administration asking that the agency recall several brands of hair-straightening products that they say contain formaldehyde.

In a May 6 letter to FDA Commissioner Margaret Hamburg, U.S. House of Representative members wrote that the Brazilian Blowout Solution and Acai Professional Smoothing Solution both contain formaldehyde, but the chemical is not listed on the product labels as an ingredient.

Rep. Earl Blumenauer (D-Ore.) had written to the agency last fall outlining complaints from Oregon hair stylists who had been experiencing acute reactions, such as nosebleeds, while working with the hair straighteners. The congressman also noted testing conducted by the Oregon Occupational Safety and Health Division and by Oregon Health and Science University found the two products contained between 6% and 12% formaldehyde.

He said that the federal Occupational Safety and Health Administration (OSHA) subsequently issued a hazard alert warning salons to steer clear of formaldehyde-based straighteners.

Formaldehyde has been recognized as a possible carcinogen and has been the subject of 47 complaints to the Environmental Working Group, members of Congress noted in the letter.

"It is clear that the FDA needs to take decisive action," they wrote.

In addition to a recall, they are seeking a warning for products that contain formaldehyde, an investigation into the companies that are claiming their products are formaldehyde free, and a review of whether the chemical should be banned from hair straighteners.

According to the May 6 letter to Dr. Hamburg, the FDA responded in late November to Rep. Blumenauer's initial letter and said that it was investigating whether the products were being marketed directly to consumers. "If so, failure to comply with the ingredient declaration requirement would constitute misbranding," responded the agency.

Ten members of Congress have written to the Food and Drug Administration asking that the agency recall several brands of hair-straightening products that they say contain formaldehyde.

In a May 6 letter to FDA Commissioner Margaret Hamburg, U.S. House of Representative members wrote that the Brazilian Blowout Solution and Acai Professional Smoothing Solution both contain formaldehyde, but the chemical is not listed on the product labels as an ingredient.

Rep. Earl Blumenauer (D-Ore.) had written to the agency last fall outlining complaints from Oregon hair stylists who had been experiencing acute reactions, such as nosebleeds, while working with the hair straighteners. The congressman also noted testing conducted by the Oregon Occupational Safety and Health Division and by Oregon Health and Science University found the two products contained between 6% and 12% formaldehyde.

He said that the federal Occupational Safety and Health Administration (OSHA) subsequently issued a hazard alert warning salons to steer clear of formaldehyde-based straighteners.

Formaldehyde has been recognized as a possible carcinogen and has been the subject of 47 complaints to the Environmental Working Group, members of Congress noted in the letter.

"It is clear that the FDA needs to take decisive action," they wrote.

In addition to a recall, they are seeking a warning for products that contain formaldehyde, an investigation into the companies that are claiming their products are formaldehyde free, and a review of whether the chemical should be banned from hair straighteners.

According to the May 6 letter to Dr. Hamburg, the FDA responded in late November to Rep. Blumenauer's initial letter and said that it was investigating whether the products were being marketed directly to consumers. "If so, failure to comply with the ingredient declaration requirement would constitute misbranding," responded the agency.

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The Field Effect [editorial]

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