Generic Vaniqa

Vaniqa Eflornithine HCl 13.9% cream is an effective treatment for the management of unwanted facial hair in women. A lot of clinical studies have been made on this medication to ensure its safety aspects for contact sensitization, photo contact sensitization, and photo contact irritation. Clinical trials with VANIQA concerned over 1370 women with unwanted facial hair of skin types I-VI, of whom 68% were White, 17% Black, 11% Hispanic-Latino, 2% Asian-Pacific Islander, 0.6% American Native, and 1.3% other.

The study revealed that under conditions of clinical use, Vaniqa Eflornithine is not likely to cause contact sensitization, phototoxic, or photosensitization reactions. Topical dermal study for contact irritation showed that VANIQA could cause irritation reactions in clinical use in susceptible individuals. It also reported negatively under conditions of excess use.

Two randomized double-blind studies were made on 594 female patients (393 treated with VANIQA, 201 with vehicle). These patients were given treatment twice daily for up to 24 weeks. It revealed the usefulness of Vaniqa Eflornithine in decreasing unwanted facial hair in women. Women in the trial had a usual frequency of removal of facial hair two or more times per week. Those women who had facial conditions such as severe inflammatory acne, pregnant and nursing mothers were not included in the studies. Physicians evaluated the improvement or worsening from the baseline condition (Physician's Global Assessment [PGA]), 48 hours after shaving, of all treated areas. Vaniqa Eflornithine hydrochloride) Cream, 13.9% showed significant improvement against vehicle in each of these studies for "marked improvement" or greater response (24-week time point; p </= 0.001). Remarkable improvement was observed constantly at 8 weeks after beginning of treatment and continued throughout the 24 weeks of treatment. When the treatment was withdrawn, Hair growth came near pretreatment levels within 8 weeks.

Just about 32% of patients reported noticeable improvement or greater (protocol definition of clinical success) after 24 weeks of treatment with Vaniqa Eflornithine hydrochloride) Cream, 13.9%, in comparison to 8% with the vehicle. These two trials when applied for 24 weeks brought the following results.

Subgroup analysis implied larger advantage for Whites than non-Whites (37% vs. 22% success, respectively; p=0.017). But, non-Whites, generally Black subjects, were benefited largely from the treatment with 22% graded as success on Vaniqa Eflornithine compared to 5% on vehicle.

About 12% of women in the clinical trials were postmenopausal. In postmenopausal women (38% compared to 0%, p </= 0.001) noteworthy improvement in PGA result versus vehicle was observed.