Dapsone gel 7.5% safe, effective for acne treatment in patients with skin of color

Key takeaways:

• By week 24, the number of lesions decreased by 53% from baseline (P < .0001).
• Sixteen adverse events occurred during the study with all of them deemed mild and unrelated to treatment.

Dapsone gel 7.5% demonstrated safety, tolerability and efficacy for the treatment of acne vulgaris in patients with skin of color, according to a study.

“Acne is the most common dermatologic diagnosis in skin of color populations,” Nour El-Kashlan, MD, dermatology resident at Icahn School of Medicine at Mount Sinai, and colleagues wrote.

In this open-label, phase 4 study, researchers examined the safety and efficacy of dapsone gel 7.5% for the treatment of moderate to severe acne vulgaris in patients with Fitzpatrick skin types IV to VI.

Twenty adult participants — 16 of which identified as Black or African American, one as Asian and three as “other” — applied the gel once a day over 24 weeks. Twelve patients completed the study.

Efficacy results showed that the mean change from baseline in Global Acne Assessment Score was –0.86 at week 12 and –1.2 at week 24 (P = .0003 and P = .001, respectively). By week 24, the number of lesions decreased by 53% from baseline (P < .0001).

The 16 adverse events reported were mild and unrelated to treatment. Six of the events were cutaneous and included dry patches, traction alopecia, pityriasis rosea, post-inflammatory hyperpigmentation and rough facial skin. The remaining adverse events were not cutaneous and included infectious events.

Overall, dapsone 7.5% was considered well tolerated, safe and efficacious in the treatment of moderate to severe acne vulgaris in patients with skin of color. However, due to the small sample size of the study, the authors suggest that further trials be conducted.

“The sample size was small and, in some cases, underpowered to detect statistically significant changes in all endpoints,” they explained. “With an increasing skin of color population in the U.S., we continue to advocate for the enrollment of patients of all skin tones in dermatologic clinical trials to accurately represent the demographics of our patients and ensure efficacy and safety among diverse populations, which we believe can help promote equity within the field.”