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

Abstract

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.

• Authors: Zoe D Draelos, Eric Carter, J Michael Maloney, Boni Elewski, Yves Poulin, Charles Lynde, Steven Garrett, United States/Canada Dapsone Gel Study Group
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 56 Issue 3 Pg. 439.e1-10 (Mar 2007) ISSN: 1097-6787 [Electronic] United States
• PMID: 17208334 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Infective Agents
• Anti-Inflammatory Agents, Non-Steroidal
• Gels
• Dapsone

Topics

• Acne Vulgaris (drug therapy, pathology)
• Adolescent
• Adult
• Anti-Infective Agents (administration & dosage, adverse effects, therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, therapeutic use)
• Child
• Dapsone (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Gels
• Humans
• Male
• Treatment Outcome