005   A novel approach to treating excessive facial hair in women. Results of safety and efficacy studies with eflornithine hydrochloride 13.9% cream.

Barbara M Mathes, Vasant Manna, Ferdinand J Huber, Joseph D Jackson, Jan Bogaerts, Kathy B Schrode, Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ, USA and Brussels, Belgium

Eflornithine, an inhibitor of ornithine decarboxylase, which appears to inhibit hair growth,was evaluated for safety and efficacy in the treatment of excessive, unwanted facial hair in women. Two double-blind, randomized, multicenter comparative studies of eflornithine hydrochloride 13.9% cream (EF) vs its vehicle, were conducted in 596 women ages 18-83 years with excessive facial hair. Eligibility included removal of facial hair at least twice weekly and presence of at least 5 terminal hairs/cm 2 in each of four areas on the face 48 hours after shaving. Subjects were randomized to EF or vehicle cream in 2:1 ratio, and applied study medication twice daily for 24 weeks followed by an 8 week no-treatment phase. The primary efficacy measure was a Physician’s Global Assessment (PGA) on a 4 point scale of the condition relative to baseline. Clinical success was defined as marked improvement or better in the subject’s condition. Secondary efficacy measures included a Subject Self-Assessment Questionnaire (SSAQ) assessing degree of bother and discomfort using a 100-point visual analog scale, and reduction in hair growth length and spatial mass using video analysis. Safety measurements were based on adverse events, clinical laboratory tests and physical examinations. Results of the studies showed EF to be superior to vehicle based on PGA at week 24. Overall, 35% of EF-treated subjects were rated clinical successes vs 9% of the vehicle-treated group, some as early as 8 weeks. 70% of EF subjects had some improvement compared to 41% on vehicle, and the percentage of subjects showing marked improvement or better increased throughout each study. Responses to the SSAQ demonstrated a very high degree of bother and discomfort with facial hair at baseline. Treatment with EF resulted in a significant improvement for all questions, and there was strong concordance between results of the PGA and the SSAQ. Video-imaging showed reduction of hair length and spatial mass for those treated with EF vs vehicle, consistent with the PGA and SSAQ results. Eight weeks after stopping therapy, there was reversion to baseline in all efficacy measures. Eflornithine cream was well-tolerated and few subjects discontinued due to adverse events. The most common adverse events were skin-related, transient and mild, not requiring dose reduction. Excessive and unwanted facial hair is a common, often distressing problem for millions of women of all ages. These studies demonstrate the safety and efficacy of treating excessive, unwanted facial hair in women with eflornithine hydrochloride 13.9% cream, by reducing the growth of hair, and provides another option in the management of this troubling condition.