Vaniqa is the first and only product that has been clinically demonstrated to be safe and effective for hair-growth reduction. Its Food & Drug Administration (FDA)-approved indicated use is for the reduction of unwanted facial hair in women. Unlike the oral hormonal treatments, which can only effect androgen-dependent hair growth, Vaniqa works on all growing hair. The pivotal Phase-III clinical studies on Vaniqa to further assess its safety and efficacy in a larger population, and to obtain regulatory approval were jointly sponsored by the Gillette Company (now P&G) and Bristol-Myers Squibb. In two randomized doubleblind studies 594 patients with terminal facial hair, self-treated twice daily with Vaniqa (393 patients) or the placebo cream without eflornithine (201 patients) for a period of 24 weeks [58]. This was followed by a no-treatment phase of eight weeks. A 48-hour hair – growth image was captured after shaving the treatment area at baseline, at several visits during the treatment period, and at the end of the follow-up period. The primary efficacy measure was improvement from baseline in the Physician Global Assessment (PGA) score based on the presence of terminal hair and darkening of the facial skin due to the terminal hair. A four-point scoring system was used for efficacy determination. The treatment group statistically showed significant improvement by the eighth week. By the end of the treatment, 35% of the subjects in the Vaniqa group showed marked improvement or better, compared to only 9% in the vehicle control group. Up to 70% of the subjects in the treatment group had at least some improvement. After stopping the Vaniqa treatment, there was a rapid recovery in hair growth. At eight weeks after treatment (follow-up) hair growth returned to near baseline levels.
In addition to the PGA scoring, there were two secondary efficacy measures: A quality of life assessment and an objective hair-growth measure [59,60]. The quality of life assessment is an important measure, as it addresses the issues that are important to the patient. A set of six questions related to the bother and discomfort that subjects with facial hirsutism feel, was administered at various intervals during the study [59]. The improvement in the ‘bother’ score from baseline was found to be at least twofold greater in the eflornithine treatment group compared to the vehicle control. At the end of the 24-week treatment period, the difference in improvement in the drug group compared to the vehicle control group was highly significant statistically, for each of the six patient-reported outcomes.
To demonstrate the quantitative changes in hair growth, a video-imaging system was used. Spatial hair mass (area in mm2) and hair growth (length in mm) were determined at various time points during the study [60]. In two separate studies, the Vaniqa treatment group reached a statistically significant difference in hair mass, compared to the placebo control, in as early as two weeks after starting the treatment, and maintained the statistical difference throughout the treatment period in both the studies.