Below is a pre-approval report on Dr. Sawaya’s work with Vaniqa under clinical conditions.
AAD: Eflornithine Hcl 15% Cream Slows Excessive Growth Of Facial Hair
SAN FRANCISCO, CA – March 10, 2000 – The results of Phase III studies involving Eflornithine HCl 15%, a topical facial cream, demonstrate significant inhibition in the rate of facial hair growth in women. The results of the Phase III trials, involving 596 women, were presented today during the 58th Annual Meeting of the American Academy of Dermatology in San Francisco, California.
It is estimated that more than 20 million American women in the United States have excessive facial hair. Excessive facial hair may be caused by hereditary factors, part of the normal aging process, or by medical conditions such as androgen excess disorder or polycystic ovarian syndrome. Women with excessive facial hair often experience psychological factors such as low self-esteem and embarrassment.
“Until now there have been no topical creams which help slow the rate of excessive hair growth,” said Marty Sawaya, M.D., Ph.D., principal investigator in the studies, adjunct professor, department of biochemistry and molecular biology at the University of Miami, and dermatologist at ARATEC Clinics in Ocala, Florida. “Women have been able to temporarily control this condition by shaving, tweezing or waxing. Based on the results of these studies, Eflornithine HCl 15% is the first topical cream that inhibits the growth rate of facial hair, thereby reducing the amount of time women have to spend managing it.”
Eflornithine HCl cream 15% has a unique mechanism of action and works by blocking an enzyme that stimulates hair growth. The Eflornithine HCl cream 15% Phase III studies were conducted to evaluate the safety and efficacy of the topical cream in the treatment of women with excessive facial hair. Approximately 596 women with excessive facial hair were randomized to Eflornithine HCl cream 15% or vehicle. The adult women who participated in the study represented a variety of ethnic groups, including Caucasians, Hispanics and African-Americans. Study treatments were applied twice daily for 24 weeks followed by an eight-week period of no treatment. Evaluations were made 48 hours after women removed facial hair.
In the Phase III studies, the primary measure of efficacy was a physician’s global assessment of improvement. The results of the physician’s global assessment at the end of the 24-week studies demonstrate significant improvement in the reduction of facial hair growth in women treated with the Eflornithine HCl cream 15% as compared to the group that was treated with vehicle (P is less than or equal to 0.001). The data from the two studies show that overall 70 percent of patients improve, and 35 percent of participants in the Eflornithine HCl group are rated as clinical successes (marked improvement or clear/almost clear) compared to nine percent in the vehicle group. The significant difference between participants on Eflornithine HCl cream 15% and those on vehicle was seen as early as after four weeks of treatment (P=0.017) in one study and after eight weeks of treatment (P is less than or equal to 0.001) in the second study. In addition, another 35 percent of participants treated with Eflornithine HCl cream 15% showed some improvement.
The reports of treatment-related adverse events with Eflornithine HCl 15% were generally comparable to vehicle. Most adverse events were mild and included stinging, burning, tingling, pseudofolliculitis barbae (PFB) and acne.
“Excessive facial hair is not only embarrassing for women – it is also time consuming to manage and can impact upon patients’ self-esteem,” said Dr. Sawaya. “As a practicing physician, I am excited about the results of the Phase III Eflornithine HCl 15% studies and the potential for a new option to help patients manage this condition.”
ARATEC Clinics conduct clinical trials in dermatology in conjunction with the University of Miami. ARATEC Clinics are based in Ocala, Florida.