Overview of New Therapeutic Developments for Acne

Anja Thielitz; Harald Gollnick

Disclosures

April 13, 2009

In This Article

Dapsone Gel

A new aqueous gel formulation of dapsone 5% (Aczone®, QLT Inc., BC, Canada) was approved by the FDA in 2005. The efficacy and safety of twice-daily dapsone 5% gel versus a vehicle gel in the treatment of acne was evaluated in 3010 patients 12 years of age and older with acne vulgaris in two identically designed 12-week, randomized, double-blind studies. In these studies, dapsone gel-treated patients achieved superior results in terms of the investigator's global acne assessment (p < 0.001) and the mean percentage reduction in inflammatory, noninflammatory and total lesion counts (p < 0.001) at week 12.[46] No clinically significant changes in laboratory parameters, including hemoglobin, even among glucose-6-phosphate dehydrogenase-deficient patients, were observed. The most common adverse events include oiliness/peeling, dryness and erythema. There were no significant differences in the adverse event rates between dapsone gel- and vehicle control-treated patients. Another 12-month, open-label, long-term safety study further evaluated the safety and efficacy of dapsone gel in patients at least 12 years of age with acne vulgaris (n = 486).[47] Application-site reactions related to treatment were reported in 8.2% of the patients and were mostly mild to moderate in severity. The mean reduction from baseline at 12 months was 58.2% for inflammatory, 19.5% for noninflammatory and 49.0% for total lesion counts (all p = 0.002).

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