Results of a Phase III clinical study using botulinum toxin type A to treat primary axillary hyperhidrosis, or excessive underarm sweating, show that botulinum toxin type A is safe and effective for treatment of hyperhidrosis and that it markedly improves quality of life in patients who suffer from this medical condition. The data were announced today at the 2004 American Academy of Dermatology (AAD) annual meeting in Washington, D.C. by Dr. Dee Anna Glaser, Associate Professor of Dermatology and Vice Chairman, Department of Dermatology, at Saint Louis University School of Medicine, a lead investigator for the trials.
"Most people dont realize that hyperhidrosis is an extremely debilitating chronic condition that affects as many as eight million people in the U.S.," said Dr. Glaser. "As such, the results of this 52-week study using botulinum toxin type A treatment are very exciting because they mean that we are that much closer to having the first truly effective, non-surgical treatment available to meet the needs of patients who suffer from primary axillary hyperhidrosis."
The study found that four weeks after treatment with botulinum toxin type A (administered intradermally), 75 percent of patients receiving botulinum toxin type A vs. 25 percent on placebo achieved at least a 2-point improvement from baseline on the Hyperhidrosis Severity Scale (HDSS), a 4-point scale. Quantity of sweat production in the axillae was also significantly decreased.
No serious treatment-related adverse events were reported. The most frequently reported treatment-related adverse events (>5 percent in any treatment group) were injection site pain, injection site hemorrhage and non-axillary sweating. The incidence of these events was not significantly different between groups.
In related research presented by Dr. Glaser at the meeting, data from the 322 patient study were used to assess the validity of the HDSS by correlating HDSS scores with items from the Dermatology Quality of Life Index and the HHIQ four weeks post-treatment. Construct validity and responsiveness were assessed by comparing post-treatment changes in HDSS score with changes in gravimetric sweat measurement and by comparing HDSS scores with various daily activity limitations due to excessive sweating as collected in a national survey mailed to 150,000 U.S. households.
Based on resulting data from these analyses, the HDSS was observed to have acceptable validity, reliability and responsiveness.
This study was funded by Allergan, Inc.
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