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

Abstract

Introduction: Post-inflammatory hyperpigmentation (PIH) that results from acne in patients with skin of color may be more distressing than the acne itself, and likely impacts patients with higher skin phototypes more greatly than those with lower skin phototypes. Topical retinoids, a mainstay of acne treatment, can also reduce hyperpigmentation. For example, significant PIH improvements with a cream formulation of the retinoid tazarotene (0.1%) were observed following 16 weeks of treatment in patients with acne. However, skin irritation and other skin reactions may limit use of some tazarotene gel and cream formulations. A hydrating, lower-dose tazarotene 0.045% lotion formulation utilizes polymeric emulsion technology to allow for more efficient delivery of tazarotene into dermal layers while reducing potential for skin irritation. This pooled, post hoc analysis evaluates safety of tazarotene 0.045% lotion and its effect on hyperpigmentation in Black individuals with acne.

Methods: In two identical phase 3 randomized, double-blind, vehicle-controlled, studies (NCT03168321; NCT03168334), participants aged ≥9 years with moderate-to-severe acne (Evaluator's Global Severity Score of 3/4) were randomized (1:1) to once-daily tazarotene 0.045% or vehicle lotion for 12 weeks. Safety evaluations included adverse events (AEs) reports and investigator-assessed hyperpigmentation (4-point scale: 0 [none] to 3 [severe]). Post hoc analyses were based on participants’ self-identification of race, including ‘Black or African American’ (herein referred to as Black).

Results: Of 1,614 participants randomized in the two phase 3 studies, 262 (16%) self-identified as Black. The safety population comprised 253 Black participants. The most common TEAEs with tazarotene 0.045% lotion were at the application site: pain (6.6%), exfoliation (5.0%), and dryness (3.3%). No Black participants reported application site irritation or dermatitis with tazarotene lotion. Hyperpigmentation rates in Black participants, which were high at baseline, decreased by week 12 with tazarotene treatment (40.5% to 31.4%) compared to vehicle (37.9% to 37.2%).

Conclusions: Acne regimens that maximize efficacy while mitigating irritation is key to managing acne in patients with skin of color, given the higher pigmentary alteration risk in melanin-rich skin. Tazarotene 0.045% lotion was safe and well tolerated in Black participants, with no application-site irritation or dermatitis after 12 weeks of once-daily treatment. Tazarotene also led to improvements in hyperpigmentation, an inflammation-associated sequala of acne. As PIH can take longer than 12 weeks to resolve with treatment, additional improvements in hyperpigmentation may be expected with continued tazarotene 0.045% lotion use.

Support: Ortho Dermatologics.