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Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris

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Background

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.

Objectives

The goal of these studies was to evaluate the efficacy and safety of dapsone gel, 5% in the treatment of acne.

Methods

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.

Results

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.

Limitations

Adjunctive topical treatments and their impact on acne were not studied in this trial.

Conclusions

Dapsone gel, 5% appears to be an effective, safe, and well-tolerated treatment for acne vulgaris, with a rapid onset of action.

Section snippets

Study design

Two 12-week, double-blind, randomized, parallel group, phase III studies were conducted under identical protocols to evaluate the efficacy and safety of dapsone gel, 5% (dapsone gel), compared with a vehicle gel control in the treatment of acne vulgaris. A total of 103 centers in the United States and Canada participated in the studies between November 2002 and September 2003.

Eligible patients were randomly assigned in a 1:1 ratio to either dapsone gel or vehicle gel according to a fixed-block

Patient disposition and baseline characteristics

A total of 3010 patients were enrolled and were dispensed dapsone gel (n = 1506) or vehicle gel (n = 1504) and made up the ITT population (Fig 1). The safety-evaluable population, defined as all enrolled subjects who applied study drug, included 1466 patients who received dapsone gel and 1467 who received vehicle gel. Approximately equal numbers from each treatment group discontinued treatment prematurely: 15.9% (240/1506) of the dapsone gel–treated patients and 17.5% (263/1504) of the vehicle

Discussion

These randomized, double-blind, vehicle-controlled studies show dapsone gel to be effective in the treatment of acne, as demonstrated by significantly greater success based on the investigator's GAAS and by the reduction of inflammatory, noninflammatory, and total lesion counts at the end of treatment. A significantly greater number of patients treated with dapsone gel than patients treated with vehicle gel had no acne or minimal acne on completion of treatment. Combined results from these two

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    Citation Excerpt :

    Dapsone is a sulfone agent that is available in a 5% gel and used as a twice-daily agent or 7.5% gel used once daily. Data only show modest-to-moderate efficacy in the reduction of inflammatory acne lesions (Draelos et al., 2007; Lucky et al., 2007). Dapsone has a poorly understood mechanism in the treatment of patients with acne and its ability to kill P. acnes has been studied poorly (Zaenglein et al., 2016).

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These studies were sponsored by QLT USA, Inc. and Astellas Pharma US, Inc.

Disclosure: Drs Draelos, Carter, Maloney, Elewski, Poulin, and Lynde were clinical investigators in the reported studies and received research support from the sponsoring companies. Dr Garrett is an employee of QLT USA, Inc.

These studies were presented in part at the 64th Annual Meeting of the American Academy of Dermatology, March 3-7, 2006, San Francisco, California.

Additional members of the United States/Canada Dapsone Gel Study Group are available at www.eblue.org as an online-only appendix to this article.

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