Vaniqa Clinical Trials

 

Results of topical dermal studies for contact sensitization, photocontact sensitization, and photocontact irritation reveal that under conditions of clinical use, VANIQA is not expected to cause contact sensitization, phototoxic, or photosensitization reactions. Results of the topical dermal study for contact irritation did reveal that VANIQA could cause irritation reactions in clinical use in susceptible individuals or under conditions of exaggerated use.

Two randomized double-blind studies involving 594 female patients (393 treated with VANIQA, 201 with vehicle) treated twice daily for up to 24 weeks evaluated the efficacy of VANIQA in the reduction of unwanted facial hair in women. Women in the trial had a customary frequency of removal of facial hair two or more times per week. Women with facial conditions such as severe inflammatory acne, women who were pregnant, and nursing mothers were excluded from the studies.

Physicians assessed the improvement or worsening from the baseline condition (Physician’s Global Assessment [PGA]), 48 hours after shaving, of all treated areas. Statistically significant improvement for VANIQA versus vehicle was seen in each of these studies for “marked improvement” or greater response (24-week time point; p£ 0.001). Marked improvement was seen consistently at 8 weeks after initiation of treatment and continued throughout the 24 weeks of treatment. Hair growth approached pretreatment levels within 8 weeks of treatment withdrawal.

The success rate over time is graphically presented below for each pivotal trial. Findings The latest results of clinical trials of Vaniqa were recently presented at the 58th Annual Meeting of the American Academy of Dermatology in March 2000. The phase III study included 596 women who were randomized to use either eflornithine HCl 15% cream or a placebo cream. The treatment was applied twice daily to the affected areas for 24 weeks, followed by an 8-week period of no treatment. The results of physician's global assessment at the end of 24 weeks demonstrated improvements in the reduction of facial hair in the women who were treated with Vaniqa. Seventy percent of the women showed improvement, with 35% being classified as clinical successes (marked improvement or clear/almost clear), compared to 9% in the placebo group. Improvement was observed as early as 8 weeks after the commencement of treatment.