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| |  AAD: Botox Highly Effective in Treating Patients for Excessive Sweating By Bruce Sylvester WASHINGTON, DC -- February 10, 2004 -- Botulinum toxin type A (Botox®) treatment appears to be safe and effective and to result in improved quality of life in primary axillary hyperhydrosis, researchers reported here February 9th at the American Academy of Dermatology 62nd Annual Meeting. "Hyperhydrosis, or excessive sweating, affects up to 8 million Americans, and is an embarrassing and debilitating condition," said co-investigator Dee Anna Glaser, MD, Associate Professor of Dermatology, St. Louis University School of Medicine, St. Louis, Missouri, United States. "The results of this study of Botox treatment are dramatic, and bring us much closer to having the first really effective and non-invasive treatment for this condition." The investigators selected subjects with hyperhydrosis of the underarm, although the site of primary axillary hyperhydrosis can occur elsewhere, such as in the hands and feet. The researchers randomised 322 subjects to 1 of 3 treatments -- 50 units of injectable Botox per underarm, 75 units per underarm, or placebo. Subjects were evaluated at week 1 and every 4 weeks thereafter for 1 year. The primary efficacy evaluation was change in the 41-item Hyperhydrosis Disease Severity Scale (HDSS), in which subjects rated severity on a 4-point scale comprising the following points: noticeable/never interferes with daily activities; tolerable/sometimes interferes; barely tolerable/frequently interferes; and intolerable/always interferes. Four weeks after 1 treatment, 75% of each Botox cohort and 25% of placebo subjects achieved at least a 2-grade improvement in HDSS scoring. Notably, 43% of Botox subjects and 12% of placebo subjects required only 1 treatment for the entire year of the study. Among subjects requiring a second treatment, 85% of the 50-unit Botox group, 74% of the 75-unit group and 27% of the placebo group reported a 2-grade improvement. Median duration of response after one treatment was 197 days, 205 days and 96 days, respectively. After the second treatment, the median response duration was 182, 159 and 63 days, respectively. Four weeks after the first treatment, mean gravimetric sweat production was also significantly decreased in both Botox groups by 82% and 87% compared to 33 in the placebo group. Four weeks after the second treatment, sweat production was decreased by 87%, 81% and 24%, respectively. Four weeks after the first treatment, patients in the Botox groups reported significantly greater quality-of-life improvements for all categories compared to those in the placebo group. "Lives have changed after 1 or 2 treatments," said Dr. Glaser. "Hyperhydrosis is a condition that causes shame, isolation and often severely diminished self esteem for millions of people. But that is not necessary."
[Study title: Botulinum Toxin Type A in Primary Axillary Hyperhidrosis: A 52-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. Abstract 195]
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