Tazarotene Led to Hyperpigmentation Improvement in Black Patients With Acne

Tazarotene 0.045% lotion use led to significant hyperpigmentation improvements in Black patients with moderate-to-severe acne, according to a poster¹ presented at the 2023 Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference in Boston, Massachusetts.

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In a post hoc analysis of 2 identical phase 3 trials, which were double-blinded, randomized, and vehicle controlled in nature (NCT03168321 and NCT03168334), researchers sought to evaluate the safety of tazarotene 0.045% lotion when used in Black patients with acne. The analysis was based on patient self-identification of race.

In the 2 trials, researchers recruited pediatric and adult participants as young as 9 years of age and older. All patients had moderate-to-severe cases of acne in accordance with the Evaluator’s Global Severity Score (EGSS). Upon inclusion, patients were randomized into 1 of 2 treatment groups: a once-daily application of either tazarotene 0.045% lotion or a vehicle-control lotion for a 12-week period.

Throughout the study, researchers had evaluated treatment-emergent adverse events (TEAEs). Additionally, they assessed and evaluated hyperpigmentation on a 4-point severity scale.

Among the participants (n=1,614) in both trials, researchers found that 16% (n=262) self-identified as Black.

Within this patient population, commonly-reported TEAEs included dryness, exfoliation, and pain at the treatment site, with pain being the most common, reported in 6.6% of Black patients.

Furthermore, rates of hyperpigmentation significantly decreased through treatment with tazarotene treatment from baseline to conclusion. In the vehicle treatment, hyperpigmentation was present in 37.9% of Black patients; at conclusion, this had decreased to 37.2%. However, more significantly, hyperpigmentation was present in 40.5% of Black patients in the tazarotene treatment group at baseline. By the conclusion of the trials, the hyperpigmentation rate had decreased by 9.1%, lowering to 31.4% after 12 weeks.

Researchers found that tazarotene 0.045% was both safe and well-tolerated among patients.

“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,” according to Cook-Bolden et al. “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.”

Reference

1. Cook-Bolden FE, Stein Gold L, Baldwin H, Callender V, et al. Safety of tazarotene 0.045% lotion and hyperpigmentation improvements in black participants with moderate-to-severe acne. Poster presented at the 2023 Society of Dermatology Physician Assistants (SPDA) Annual Summer Dermatology Conference; June 22-25, 2023; Boston, MA.