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Feb. 22, 2005 (New Orleans)  A new topical gel containing 5% dapsone is showing promise in the treatment of acne vulgaris, according to results from two studies reported here at the 63rd annual meeting of the American Academy of Dermatology.

Both studies showed that the dapsone resulted in a substantial reduction in both inflammatory and noninflammatory acne with minor adverse effects, such as mild to moderate reactions at the site of treatment, headache, and runny nose.

"Topically, this is a novel approach to treating acne," said Guy Webster, MD, moderator of the poster session at which the data were presented and vice chairman of the department of dermatology at Jefferson Medical College in Philadelphia, Pennsylvania. "It will be nice to have something different for a change." Dr. Webster was not involved in the studies.

In the first study, a randomized, double-blind, multicenter trial, dapsone topical gel was substantially more effective than vehicle gel in the treatment of 496 acne patients.

"Dapsone 5% represents a novel, effective, and safe topical therapy for the treatment of acne vulgaris," said David Wilson, MD, a dermatologist in private practice in Forest, Virginia, who was lead author of the randomized trial.

In Dr. Wilson's study, 330 patients were treated with dapsone and 166 others were treated with vehicle gel. The majority of patients had moderately severe acne.

At the end of 12 weeks of treatment, improvement in the dapsone-treated group was significantly greater than that in the vehicle group. More than one fourth (26.7%) of the treated group had a Global Acne Assessment of less than 2 compared with 16.8% of the placebo group. (The Global Acne Assessment is scored from 0 to 4, with 0 being "clear, no inflammatory lesions," and 4 being "severe or cystic acne.")

Of patients with inflammatory acne, treatment with dapsone resulted in a mean 37.2% reduction in lesions in the dapsone-treated group compared with a 26.6% reduction in lesions in the vehicle group. Of the noninflammatory acne patients, 27.5% of dapsone-treated patients had lesion reduction vs 16.8% in the vehicle group. Overall, those treated with dapsone had a 32% reduction in total lesion counts vs 21.9% in the vehicle group. Dapsone-treated patients had few adverse reactions; 2% had site reactions that were mild in severity.

"It was effective and more effective than placebo," said Dr. Wilson. "The global assessment [improvement] of acne was not huge, but it was real. And topically it proved to be quite safe."

The second study  a multicenter, open-label trial of 506 patients  showed the gel was both safe and effective in patients with acne vulgaris.

In the open-label study, patients showed improvement in acne at one month that continued throughout the one-year study period. During the 12 months, inflammatory acne counts were reduced by 58.2%; noninflammatory lesions decreased 19.5%, and total lesions counts were reduced by 49.0%. If the acne cleared, then patients could stop using the gel and start it up if they needed it again.

"We saw improvement in patients at one, three, six, and up to 12 months," said co–study author Michael Maloney, MD, a dermatologist in private practice in Denver, Colorado, who presented the results. "This was a long-term study, and we saw beneficial effects in both inflammatory and noninflammatory acne."

In the study, patients aged 12 to 77 years applied the dapsone 5% topical gel twice daily for up to one year. A total of 340 patients completed one year of treatment. At baseline, participants had a mean total facial acne lesion count of 87.0, including 48.0 inflammatory and 38.5 noninflammatory lesions.

Adverse effects of dapsone were mild to moderate and few patients (2.3%) withdrew from treatment. The most commonly reported adverse effects, regardless of the cause, included headache (20%), common cold (15%), and pharyngitis (9%). Most common application site adverse effects were dryness or rash (3%).

Dr. Webster said that dapsone, in the oral formulation, is an anti-inflammatory presently used in leprosy and HIV-associated diseases. However, while the oral version of the drug has marked adverse effects, the topical version appears to have few. "Taken orally it can be quite worrisome," he said. "But taken topically it has next to no side effects."

Dapsone is both an anti-inflammatory as well as an anti-infective that targets the microorganisms that cause the inflammation in acne and calms the neutrophils involved, Dr. Webster said. "It could be very useful as a topical drug for acne," he said.

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