LAS VEGAS — After years of delay, topical dapsone gel 5% can now be prescribed for patients with mild to moderate acne, marking the first new chemically based drug treatment for acne in a decade.
A sulfone drug, Aczone 5% gel has anti-inflammatory and antimicrobial properties.
“It's a drug we know well from dermatitis herpetiformis and other diseases,” said Dr. Guy Webster at a dermatology seminar sponsored by Skin Disease Education Foundation.
However, the topical gel form appears to be a much safer drug, free from the hemolysis, hemolytic anemia, and peripheral neuropathy that can result from oral administration of the drug for Hansen's disease or serious skin disorders, he said.
No blood tests will be required for patients receiving topical dapsone, based on an FDA revision of drug labeling for the product last March.
In clinical trials involving more than 3,000 patients, the inflammatory lesion count among patients receiving active dapsone gel declined 24% within 2 weeks.
The total lesion count declined 48% in patients receiving dapsone gel by week 12, a statistically superior result to the 42% lesion count reduction seen in patients who received the vehicle alone.
Side effects were mostly mild and similar to the profile seen with other topical acne products. They included erythema, dryness, oiliness, and peeling.
“This is going to be a very, very safe drug, very well tolerated,” said Dr. Webster days before the drug was launched. “There are no safety worries.”
He predicted the gel will be prescribed as a first-line treatment for patients with mild to moderate acne but said it remains to be seen whether topical dapsone will ultimately play a role in treating patients with severe acne, either alone or in combination with other drugs.
Dr. Webster disclosed that he is a consultant to Allergan.
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