Safety of Tazarotene 0.045% Lotion and Hyperpigmentation Improvements in Black Participants With Moderate-to-Severe Acne

Introduction: Post-inflammatory hyperpigmentation (PIH) that results from acne in patients with skin of color may be more distressing than the itself, and likely impacts higher phototypes greatly those lower phototypes. Topical retinoids, a mainstay treatment, can also reduce hyperpigmentation. For example, significant PIH improvements cream formulation retinoid tazarotene (0.1%) were observed following 16 weeks treatment acne. However, irritation other reactions limit use some gel formulations. A hydrating, lower-dose 0.045% lotion utilizes polymeric emulsion technology to allow for efficient delivery into dermal layers while reducing potential irritation. This pooled, post hoc analysis evaluates safety its effect on Black individuals acne.
 Methods: In two identical phase 3 randomized, double-blind, vehicle-controlled, studies (NCT03168321; NCT03168334), participants aged ≥9 years moderate-to-severe (Evaluator's Global Severity Score 3/4) randomized (1:1) once-daily or vehicle 12 weeks. Safety evaluations included adverse events (AEs) reports investigator-assessed (4-point scale: 0 [none] [severe]). Post analyses based participants’ self-identification race, including ‘Black African American’ (herein referred as Black).
 Results: Of 1,614 studies, 262 (16%) self-identified Black. The population comprised 253 participants. most common TEAEs at application site: pain (6.6%), exfoliation (5.0%), dryness (3.3%). No reported site dermatitis lotion. Hyperpigmentation rates participants, which high baseline, decreased by week (40.5% 31.4%) compared (37.9% 37.2%).
 Conclusions: Acne regimens maximize efficacy mitigating is key managing color, given pigmentary alteration risk melanin-rich skin. Tazarotene was safe well tolerated no application-site after treatment. led hyperpigmentation, an inflammation-associated sequala As take longer resolve additional expected continued use.
 Support: Ortho Dermatologics.