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| |  AAD: Topical Dapsone Gel Appears Safe and Effective in Long-Term Use Against Acne By Ed Susman NEW ORLEANS, LA -- February 21, 2005 -- A dapsone topical gel under development clears acne lesions effectively and can be used safely for at least as long as a year, according to research presented February 20th at the 63rd annual meeting of the American Academy of Dermatology. In a 12-week trial, patients using the 5% dapsone gel achieved a 26.7% success in Global Acne Assessment compared to 16.8% success in patients receiving a look-alike vehicle gel. "These results didn’t show a huge difference in rates," said David Wilson, MD, an investigator with the Educational and Research foundation, Inc., in Lynchburg,Virginia. "But the difference is real and is statistically signifcant at the P=.042 level." In his study, Dr. Wilson recruited 330 patients with acne vulgaris to use the active product and 166 patients to use just the vehicle gel. The patients had moderately severe acne with lesion counts averaging about 90. The patients in the double-blind study receiving the active drug showed statistically significant advantages over placebo in treating inflammatory lesions, non-inflammatory lesions, and in total lesion counts. "We often see a substantial improvement in the placebo group in these trials," said session moderator Guy Webster, MD, professor and vice chairman of dermatology at Jefferson Medical College, in Philadelphia, Pennsylvania, "which may be due to the vehicle itself or better skin care that occurs during clinical trials." Dr. Webster noted that dapsone is an older drug that was often used systemically, but as a systemic drug had a difficult adverse effect profile. That did not appear to be a problem with the topical drug. In a poster discussion session, Dr. Wilson said, "the majority of treatment-related adverse events were application site reactions, reported by fewer than 2% of patients. The events were mild in severity and were not significantly different between the treatment groups." In a second study, Michael Maloney, MD, a private practice physician at Cherry Creek Dermatology, in Denver, Colorado, looked at treatment with dapsone over a year in which patients used the gel twice a day when there was acne activity. He and colleagues in the multi-center trial enrolled 506 patients between the ages of 12 and 77. He said 340 patients finished the trial. The most common side effect during the 12-month trial was headache and the common cold. The adverse events required discontinuation from the trial in 2.3% of patients, he said. Overall, total lesion counts were reduced 49% from baseline during the trial, but inflammatory lesions decreased by 58.2%; non-inflammatory lesions were decreased 19.5%, Dr. Maloney reported. "Dapsone is a really interesting drug," said Dr. Webster. "It inhibits neutrophil-mediated inflammation. It would be nice to have something new for acne." According to Dr. Maloney, the companies that supported the clinical trials, Fujisawa Healthcare, Inc., and Atrix Laboratories, Inc., have submitted an application for approval of the gel with the United States Food and Drug Administration.
[Study titles: 5% dapsone topical gel: safety and efficacy with long-term (1 year of treatment for acne vulgaris; Abstract P20. Dapsone gel 5% is an effective, safe, novel topical treatment of acne vulgaris; Abstract P21]
Access by news media is prohibited to numerous sessions of the American Academy of Dermatology annual meeting. This report is based on a presentation for which coverage was permitted by the Academy.
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