Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: First of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-controlled Trials

May 2016 | Volume 15 | Issue 5 | Original Article | 553 | Copyright © May 2016

Linda F. Stein Gold MD,a Michael T. Jarratt MD,b Alicia D. Bucko DO,c Steven K. Grekin DO,d
Joshua M. Berlin MD,e Michael Bukhalo MD,f Jonathan S. Weiss MD,g David R. Berk MD,h
Joan–En Chang–Lin PhD,h Vince Lin PhD,h and Alexandre Kaoukhov MDh

aDepartment of Dermatology, Henry Ford Medical Center, Detroit, MI
bDermResearch, Inc, Austin, TX
cAcademic Dermatology Associates, Albuquerque, NM
dGrekin Skin Institute, Warren, MI
eDermatology Associates, PA, of the Palm Beaches. Boynton Beach, FL
fAltman Dermatology Associates, Arlington Heights, IL
gGwinnett Dermatology, PC, Snellville, GA
hAllergan plc, Irvine, CA

BACKGROUND: Treatment of acne vulgaris (acne) with dapsone gel, 5% requires twice-daily dosing, and some patients may not adhere to this regimen.
OBJECTIVE: The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P<.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P<.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of “none” for stinging/burning, dryness, scaling, and erythema scales at all time points.
CONCLUSIONS: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.

J Drugs Dermatol. 2016;15(5):553-561.
Acne vulgaris (acne), one of the most frequently diagnosed dermatologic disorders across multiple age groups,1 can negatively affect quality of life (QOL) and is associated with low self-esteem and symptoms of depression and anxiety.2-4 Effective acne therapy can improve QOL and ameliorate depression and anxiety symptoms.2,5
Effective topical agents for acne include benzoyl peroxide, retinoids, antibiotics,6 and dapsone. Dapsone, a sulfone compound with anti-inflammatory properties, has been available as an oral agent for more than 60 years.7,8 Dapsone gel, 5% (Aczone® Gel; Allergan plc, Dublin, Ireland) is approved for the treatment of acne.9
In clinical trials, patients receiving dapsone gel, 5% twice daily experienced significant improvement versus vehicle (P≤.002) in inflammatory and noninflammatory lesions, with effectiveness sustained through 1 year of open-label treatment.10,11 Dapsone