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.
RCT Entities:
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-deficientpatients, 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: Diane M Thiboutot; Leon Kircik; Amy McMichael; Fran E Cook-Bolden; Stephen K Tyring; David R Berk; Joan-En Chang-Lin; Vince Lin; Alexandre Kaoukhov Journal: J Clin Aesthet Dermatol Date: 2016-10-01
Authors: Angela Yen Moore; Edward L Lain; Amy McMichael; Leon Kircik; Andrea L Zaenglein; Adelaide A Hebert; Ayman Grada Journal: J Clin Aesthet Dermatol Date: 2021-04-01
Authors: Eran Shavit; Afsaneh Alavi; Falk G Bechara; Richard G Bennett; Marc Bourcier; Ricardo Cibotti; Steven Daveluy; John W Frew; Amit Garg; Iltefat Hamzavi; Lauren K Hoffman; Jenny Hsaio; Joslyn Sciacca Kirby; Hadar Lev-Tov; Erin Martinez; Robert Micheletti; Haley B Naik; Aude Nassif; Cynthia Nicholson; Angie Parks-Miller; Zarine Patel; Vincent Piguet; Mayur Ramesh; Barry Resnik; Christopher Sayed; Gregory Schultz; Aamir Siddiqui; Jerry Tan; Ximena Wortsman; Michelle A Lowes Journal: Exp Dermatol Date: 2019-01 Impact factor: 3.960