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Pseudofolliculitis BarbaeDr. Hordinsky presented research on pseudofolliculitis barbae, a common disprescription among African American men who develop inflammatory papules, pustules, hyperpigmentation, and scarring on the face and neck. These lesions have perifollicular mononuclear cell infiltrates around curved hair follicles and occasionally microabscesses that resemble acne.Dr. Hordinsky described her pilot study results using topical eflornithine (Vaniqua), an ornithine decarboxylase inhibitor. Ornithine decarboxylase is present in hair follicles and their cortical cells, increased in anagen follicles, and decreased in telogen follicles. Eflornithine is a cytostatic, reversible, dose-dependent ornithine decarboxylase inhibitor and thereby inhibits hair follicle growth. It is FDA-approved as a safe, effective therapy for unwanted facial hair in women. Dr. Hordinsky was enthusiastic about the results of her pilot study but cautioned that more studies need to be done to prove that topical eflornithine is useful off-label therapy for pseudofolliculitis barbae.
Hair: Wanted and UnwantedUnwanted facial hair affects more that 20 million women who treat themselves 1 or more times per week. Dr. Sawaya cited family, friends, and personal experience to indicate that unwanted facial hair is often familial but always a problem. Localized and generalized hirsutism may be due to hormonal imbalance, medications, aging, porphyria cutanea tarda, or polycystic ovary syndrome. Women plagued with this problem often try many approaches, such as bleaching, shaving, depilation, plucking, waxing, sugaring, electrolysis, and, more recently, lasers. Dr. Sawaya was enthusiastic about the recent FDA approval of 13.9% eflornithine hydrochloride cream for the reduction of unwanted facial hair in women. In 2 randomized, double-blind clinical trials, 32% of patients treated with eflornithine cream showed marked improvement or greater after 24 weeks of treatment compared with 8% of patients treated with vehicle.[4] A Vaniqa prescription will cost approximately $25 per month to treat a limited area, so it may not be useful for hirsutism that affects large areas such as the back or trunk. (It should be noted that the drug has only been studied on the face and adjacent areas under the chin, and it is labeled for reduction of facial hair only.) Given the early evidence of effectiveness, Dr. Sawaya predicts that many women will seek out dermatologists for Vaniqa prescriptions before seeking laser hair removal procedures. Dr. Sawaya also discussed the potential off-label use of the 5-mg pill of finasteride (Propecia) to treat hirsutism in appropriately selected women. This suggestion was based on recent findings that serum prostate-specific antigen is an important marker or indicator of androgen activity in women. Endocrinologists and obstetrician-gynecologists are actively investigating the use of finasteride in idiopathic hirsutism, so definitive data are accumulating as to its safety, effectiveness, and specific indications. Dr. Sawaya proposed that finasteride is as effective as spironolactone and flutamide but has a better safety profile in the treatment of idiopathic hirsutism. In the next few years, Dr. Sawaya predicts the off-label use of finasteride in selected populations of women, especially if studies on the correlation of serum prostate-specific antigen and androgen activity in women are substantiated. Marty E. Sawaya, MD, PhD, ARATEC Clinics, Ocala, Florida, discussed the latest developments in the treatment of "too much and too little hair." Human Dermal Safety Studies with Eflornithine HCl 13.9% Cream (VaniqaTM), a Novel Treatment for Excessive Facial HairEflornithine HCl 13.9% cream (VaniqaTM) is a novel treatment for the management of unwanted facial hair in women.This paper reports the results of four modified open-label, within-subject vehicle-controlled studies evaluating the dermal safety of this topical treatment. In a repeated insult patch test (230 subjects), erythema with oedema occurred in 38.9% of subjects treated with eflornithine HCl 13.9% cream and 4.8% of subjects treated with vehicle cream. Challenge applications at previously untested sites following the three-week induction period produced noticeable erythema or greater on only four sites treated with eflornithine HCl 13.9% cream and one vehicle-treated site. The erythema at these sites subsided substantially within 24 hours. In a three-week cumulative irritation study (30 subjects), the mean irritation score for sites treated with eflornithine HCl 13.9% cream was 1.33, compared with 0.76 at vehicle-treated sites and 3.09 at positive-control (sodium lauryl sulphate-treated) sites (p < 0.001 between all three groups). In a phototoxicity study (25 subjects), irradiated sites showed either no reaction (40% of both sites treated with eflornithine HCl 13.9% cream and vehicle-treated sites), or mild erythema subsiding in all cases but one within 24 hours. No reaction was seen at non-irradiated sites. In a photocontact allergy study (30 subjects), challenge with eflornithine HCl 13.9% cream or its vehicle alone produced either no reaction or mild erythema subsiding within 24 hours at both irradiated and non-irradiated sites. No serious adverse events were reported during the studies, and the only adverse events considered related to treatment were pruritus (three subjects) and dry skin at test site (one subject). These results demonstrate that eflornithine HCl 13.9% cream does not have contact sensitising, photocontact allergic or phototoxic properties. It can cause irritation under exaggerated conditions of use. Eflornithine HCl 13.9% cream, therefore, has a favourable dermal safety profile appropriate for a topical treatment to be applied routinely. Janet G. Hickman, Education and Research Foundation Inc., Lynchburg, VA 24501, USA; Ferdinand Huber and Maria Palmisano, Bristol Myers Squibb, Princeton, NJ 08540,
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