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| |  AAD: Eflornithine Helps Women Battle Excessive Facial Hair NASHVILLE, TN -- August 4, 2000 -- Whether they tweeze, wax or use over-the-counter depilatories, women with excessive facial hair spend a great deal of time and money searching for the best way to keep facial hair from growing back. But as these women soon find out, the hair always grows back. Now, a new topical cream could offer long-term relief for millions of women who suffer with the physical and psychological effects of excessive facial hair. Speaking today at Academy 2000, the American Academy of Dermatology’s summer scientific meeting in Nashville, dermatologist Marty Sawaya, M.D., Ph.D., principal investigator of clinical research, Aratec Clinics, Ocala, FL, discussed a new topical cream that significantly reduces the rate of excessive facial hair growth in women. "Unwanted facial hair is a common, chronic medical condition that affects more than 40 million women in the United States," said Dr. Sawaya. "In addition to hereditary factors, excessive facial hair may be caused by medical conditions such as androgen excess disorder of polycystic ovarian syndrome. Regardless of the cause, excessive facial hair has been shown to have a major psychological impact on women, such as low self-esteem." Eflornithine (HC1 cream) 15% is a new topical cream that has been shown to significantly reduce the rate of excessive facial hair growth in women. The cream has a unique mechanism of action and works by blocking an enzyme that stimulates hair growth. In Phase III studies of Eflornithine (HC1 cream) 15%, approximately 596 women with excessive facial hair were randomly selected to receive either eflornithine (HC1 cream) 15% or a control to evaluate the product’s safety and efficacy. The adult women who participated in the study represented a variety of ethnic groups, including Caucasians, Hispanics and African Americans. The study treatments were applied twice daily for 24 weeks followed by an eight-week period of no treatment. In the Phase III studies, the primary measure of efficacy was a physician’s global assessment of improvement. At the end of the 24-week studies, physicians assessed that the women treated with the eflornithine (HC1 cream) 15% showed significant improvement in the reduction of facial hair growth compared to the group that was treated with the control. "The data from the two studies show that overall 70 percent of patients improve, and 35 percent of participants in the eflornithine HC1 group are rated as clinical successes showing marked improvement compared to only 9 percent in the control group," explained Dr. Sawaya. In addition, the reports of treatment-related side effects with eflornithine (HC1 cream) 15% were mild and generally comparable to the control -- including stinging, burning, tingling, ingrown hairs and acne. As part of the Phase III eflornithine (HC1 cream) 15% studies, investigators utilized a unique self-assessment questionnaire designed to assess the impact of eflornithine (HC1 cream) 15% on women with excessive facial hair. This assessment tool, coined IMAGE, was created to measure women’s feelings of discomfort and bother from facial hair in these areas -- intimacy or in exchanges of affection; meeting new people; amount of time spent removing facial hair; gatherings with people in social and professional environments; and esteem. Each participant in the study completed the self-assessment questionnaire at the start of the study, as well as at intervals during the study and at the end of the study. "The results of the IMAGE questionnaire are really remarkable in that there was a significantly greater decrease in the level of bother and discomfort in women treated with eflornithine (HC1 cream) 15% than those on the control," said Dr. Sawaya. At the start of the study, the average level of bother and discomfort reported by the 596 participants was greater than 80 -- based on a 0-100 scale in which 0 represented "not bothered/uncomfortable" and 100 represented "extremely bothered/uncomfortable." Results at the end of the study showed that on average women treated with eflornithine (HC1 cream) 15% reported more than a two times greater reduction in their level of bother and discomfort as compared with those on the control. Eflornithine (HC1 cream) 15% was recently approved by the U.S. Food and Drug Administration for treating excessive facial hair growth in women. Women should consult their dermatologist to determine the appropriate course of treatment based on their condition.
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