Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris - 12/08/11
, Eric Carter, MD b, J. Michael Maloney, MD c, Boni Elewski, MD d, Yves Poulin, MD e, Charles Lynde, MD f, Steven Garrett, DDS gfor the United States/Canada Dapsone Gel Study Group
Reprint requests: Zoe D. Draelos, MD, Dermatology Consulting Services, 2444 N Main St, High Point, NC 27262.High Point, North Carolina; New York, New York; Denver and Fort Collins, Colorado; Birmingham, Alabama; Sainte-Foy, Quebec, and Markham, Ontario, Canada
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.
El texto completo de este artículo está disponible en PDF.Abbreviations used : GAAS, G6PD, ITT
Esquema
| 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. |
Vol 56 - N° 3
P. 439.e1-439.e10 - mars 2007 Regresar al número
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