Dapsone 5% Gel: A New Option in Topical Therapy for Acne

Jerry Tan, MD, FRCPC


Skin Therapy Letter. 2012;17(8):1-3. 

In This Article

Evidence for Efficacy

Two identically designed 12 week phase 3 double-blind randomized vehicle-controlled trials in acne (total N=3010) have been performed.[2] The objective of these studies was to evaluate the efficacy and safety of twice daily topical dapsone 5% gel in acne vulgaris. Subjects were aged 12 years or older with facial acne, including 20–50 inflammatory lesions and 20–100 noninflammatory lesions at baseline. The primary efficacy endpoints were global success (achievement of clear or minimal on global assessment) and mean percent reduction from baseline in lesion counts. Baseline characteristics for the vehicle and active treatment groups were similar, with the majority of patients having moderate acne (58%) and a third (33%) having mild acne. At end of the study, 41% of the dapsone gel cohort achieved global success, compared with 33% of patients treated with vehicle (P>0.001). Significant reduction in non-inflammatory, inflammatory, and total lesion counts were noted in dapsone gel versus vehicle groups (32% versus 24%, 39% versus 32%, 48% versus 42%, all P>0.001, respectively).[2]

The efficacy of dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4%, or moisturizer was evaluated in a 12 week double-blind randomized study involving 301 acne subjects.[3] Dapsone gel was applied twice daily and 1 of the 3 additional treatments was applied once daily. Subjects treated with dapsone gel and adapalene showed a significantly greater improvement in non-inflammatory and total lesion count reduction compared to dapsone gel and moisturizer. The dapsoneadapalene treatment group showed a slightly higher incidence of application site burning. Overall, local adverse reactions were minimal and generally mild in severity and improved during treatment. Seven patients in the dapsone gel and benzoyl peroxide group reported temporary tan/brown residue at application sites. However, this discolored residue could be wiped away if observed. The authors suggest that, when used together, the first product should be completely absorbed prior to application of the second, without a visible layer of either product on the skin after application. Alternatively, application of these agents at different times of the day can obviate this discoloration.