An Open-label Study to Investigate the Efficacy and Tolerability of Dapsone Gel, 7.5% in the Treatment of Acne Vulgaris in Men and Women With Skin of Color

June 2024 | Volume 23 | Issue 6 | 410 | Copyright © June 2024


Published online May 30, 2024

doi:10.36849/JDD.7897

Nour El-Kashlan MDa, Ahuva Cices MDa, Bridget Kaufman MDa, Joel Correa Da Rosa PhDa, Ingrid Sanabria-Gonzalez AAa, Saakshi Khattri MDa, Andrew Alexis MD MPHb

aDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY 
bDepartment of Dermatology, Weill Cornell Medicine, New York, NY

Abstract
Introduction: Acne vulgaris is a common skin disease prevalent in skin of color patients. Studies have demonstrated that dapsone gel, 7.5% (Aczone) used once daily is effective, safe, and well-tolerated for the treatment of acne in both men and women. However, minimal data are available in skin of color populations. This single-center, open-label clinical study investigated the efficacy and safety of dapsone gel, 7.5% in the treatment of moderate to severe acne vulgaris in patients with Fitzpatrick skin types IV-VI.
Methods: Twenty (20) adult subjects with moderate to severe acne and Fitzpatrick skin types IV-VI were enrolled in this study and treated with dapsone gel, 7.5% once daily for 24 weeks.
Results: Dapsone gel, 7.5% applied daily for 24 weeks reduced acne severity, post-inflammatory hyperpigmentation, and decreased new inflammatory and noninflammatory acne lesions in skin of color patients with moderate to severe acne vulgaris. Treatment resulted in improved acne health-related quality of life and patient symptoms related to acne, including patient-reported post-inflammatory hyperpigmentation, especially with a treatment duration of 18 weeks or longer. 
Limitations: The sample size was small and underpowered to detect statistically significant changes in some endpoints.
Conclusion: Dapsone gel 7.5% was safe, well-tolerated, and efficacious in treating acne vulgaris and post-inflammatory hyperpigmentation in skin-of-color patients. Larger studies involving skin-of-color populations with acne vulgaris are warranted.

J Drugs Dermatol. 2024;23(6):410-417. doi:10.36849/JDD.7897

BACKGROUND

Acne vulgaris is a common skin disease characterized by inflammatory papules, pustules, and comedones that is prevalent in men and women of color. Acne is the most common dermatologic diagnosis in skin of color (SOC) populations.1 Although individuals of all skin types can develop acne vulgaris, there are important differences in darker skin types that are important to consider when choosing an optimal treatment.2

Acne in women of color is more likely to present on the cheek area, compared to a predominance of chin and cheek lesions in white women.2 Notably, women of color are more likely to develop complications from acne including keloids, hypertrophic scars, and post-inflammatory hyperpigmentation (PIH).3 PIH may last for weeks to months and, in many cases, is more troublesome to patients than the acne itself.2 Overall, facial acne and its sequelae have a greater impact on the perception of appearance, negative emotions, and social functioning in women of color than in white women.

Dapsone is a sulfone compound with anti-inflammatory properties that has been shown to be effective in the treatment of acne vulgaris in SOC.4 Dapsone gel, 5% administered twice daily has been associated with significant improvement in overall acne severity, acne signs, and impact on quality of life (QOL) in women of color.4 Two phase III trials of a newer formulation of dapsone gel, 7.5% used once daily demonstrated that this product is effective, safe, and well-tolerated for the treatment of acne in both men and women.5 However, minimal data is available regarding its efficacy and safety in SOC patients. 

Further, investigators in the phase IV study of dapsone gel 5% for acne in SOC anecdotally reported improvement in hyperpigmentation over 12 weeks.4 Further research is needed on the potential effects of dapsone gel on hyperpigmentation and PIH in SOC patients with acne. 

This study investigates the therapeutic impact of dapsone gel in adult acne patients with SOC. Uniquely, this study also evaluates the impact of dapsone gel on post-inflammatory