Clinical Experience With Once-Daily Dapsone Gel, 7.5% Monotherapy in Patients With Acne Vulgaris

June 2018 | Volume 17 | Issue 6 | Original Article | 602 | Copyright © June 2018

Toni C. Stockton MD,a Emil A. Tanghetti MD,b Edward Lain MD,c Joshua A. Zeichner MD,d and Nancy Alvandi PhDe

aStockton Dermatology, Phoenix, AZ bCenter for Dermatology & Laser Surgery, Sacramento, CA cAustin Institute for Clinical Research, Austin, TX dThe Mount Sinai Hospital, New York, NY eAllergan plc, Irvine, CA

BACKGROUND: Dapsone gel, 7.5% is a topical medication approved for acne in patients aged 12 years and older. Clinical trials have demonstrated the safety and efficacy of once-daily dapsone gel, 7.5% in patients with moderate acne. OBJECTIVE: The objective of this report is to describe the clinical course of 8 patients who participated in a 12-week program using once-daily dapsone gel, 7.5% as monotherapy for acne in a real-world clinical setting. MONOTHERAPY PROGRAM: Male and female adults and adolescents with facial acne, representing a broad range of ages, skin phototypes, and ethnicities, and with no prior use of dapsone gel, 7.5% applied the product once daily for 12 weeks as monotherapy for acne. Photographs were taken at baseline and at 12 weeks. The treating dermatologists recorded observations of baseline disease, treatment tolerability, and outcomes. An independent rater assessed Global Acne Assessment Score (GAAS) at baseline and at 12 weeks based on photographs. Patients provided testimonials of their experience with treatment. PROGRAM OUTCOMES: Acne improvement was evident in the photographs of the 8 patients. Changes in GAAS at week 12 of treatment, as assessed by an independent rater, ranged from 1- to 3-grade improvement from baseline. CONCLUSION: Photographs, dermatologist reports, and patient commentary in an office-based practice demonstrated that 12 weeks of treatment with only topical dapsone gel, 7.5%, applied once daily, was effective and well tolerated as a stand-alone treatment in 8 patients with facial acne vulgaris, with results that are consistent with the phase 3 pivotal trials. J Drugs Dermatol. 2018;17(6):602-608.


Patients with facial acne vulgaris may contend with painful inflammatory lesions and an appearance altered by erythema, comedones, residual discoloration, and scarring.1-7 They often experience poor self-confidence and quality of life.1,7,8 It is routine to address the manifold acne lesion types and severity levels through a multimodal approach involving oral and topical medications.3,9 Dapsone gel, 7.5% (Aczone Gel, 7.5%; Allergan plc, Dublin, Ireland) is a once-daily topical medication approved by the US Food and Drug Administration (FDA) to treat acne vulgaris in patients aged 12 years and older.10 Its once-daily application may benefit patients by helping to improve their adherence to treatment.11 Pivotal clinical trials demonstrated that dapsone gel, 7.5% was safe, well tolerated, and effective as once-daily monotherapy in patients with moderate acne.11-13 The strictly controlled conditions of a clinical trial may not predict the experiences and treatment outcomes likely to occur with the use of a medication in real life.14 A 12-week program was initiated to evaluate the use of once-daily dapsone gel, 7.5% as monotherapy for acne in an office-based practice, with dermatologists identifying candidates for treatment with dapsone gel, 7.5% based on indications defined by the drug’s prescribing information. Consistently with real-life clinical presentations of acne,15 the program included male and female adolescents and adults representing a variety of acne phenotypes, Fitzpatrick skin phototypes, races, and ethnicities. This paper presents the clinical courses and before- and after-treatment photographs for 8 patients who participated in this program.

Dapsone Gel, 7.5% Monotherapy Program

Dermatologists from 5 locations in New York, California, Texas, and Arizona identified male and female patients aged 12 to 45 years with facial acne and no prior use of the product to receive dapsone gel, 7.5% once daily as monotherapy for acne vulgaris according to the FDA-approved indication. Patients applied dapsone gel, 7.5% once daily for 12 weeks as the only prescription acne medication during the treatment