Clinical Health Updates

Dapsone gel effective for acne vulgaris treatment

Clinical Question:
Is dapsone gel 5% effective in the treatment of acne vulgaris?

Bottom Line:
Dapsone gel 5% (Aczone) is marginally more effective than placebo (NNT = 13, 9-23) in the treatment of acne vulgaris. At 12 weeks of treatment, less than half the patients in the treatment group received acne assessment scores of “none” or “minimal”. No serious adverse events were reported, but data from follow-up longer than 3 months is forthcoming.

Draelos ZD, Carter E, Maloney M, et al. Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris. J Am Acad Dermatol 2007;published online 1/4/07.

Study Design:
Randomized controlled trial (double-blinded)

A new aqueous gel formulation of dapsone has been developed that allows clinically-effective doses of dapsone to be administered topically with minimal systemic absorption. The authors evaluated the efficacy and safety of dapsone gel, 5% in the treatment of acne. Patients 12 years of age and older with acne vulgaris (N = 3010) participated in two identically-designed 12-week, randomized, double-blind studies of twice-daily monotherapy with dapsone gel, 5%, versus a vehicle gel. Dapsone gel-treated patients achieved superior results in terms of the investigator’s global acne assessment (P < .001) and the mean percentage reduction in inflammatory, noninflammatory, and total lesion counts (all, P < .001) at week 12. Reductions in inflammatory lesion counts favoring dapsone gel over vehicle were apparent as early as 2 weeks and reached statistical significance by 4 weeks. No clinically significant changes in laboratory parameters, including hemoglobin, even among glucose-6-phosphate dehydrogenase-deficient patients, were observed. Adverse events were comparable between the treatment groups and rarely led to discontinuation.
Adjunctive topical treatments and their impact on acne were not studied in this trial.