Dermal sensitization, safety, tolerability, and patient preference of tazarotene 0.045% lotion from five clinical trials

Document Type

Journal Article

Publication Date

6-1-2022

Journal

The Journal of dermatological treatment

Volume

33

Issue

4

DOI

10.1080/09546634.2021.1944969

Keywords

Topical; retinoid; safety; tazarotene

Abstract

BACKGROUND: Topical retinoids are recommended for acne treatment, but their use may be limited by irritation or dermatitis. Herein is an overview of the dermal sensitization, safety, tolerability, and participant satisfaction data from phase-1, -2, and -3 studies of lower-dose tazarotene 0.045% polymeric emulsion lotion. METHODS: Two phase-1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase-2 (NCT02938494) and two phase-3 studies (NCT03168334; NCT03168321) were double-blind, randomized, and vehicle-controlled over 12 weeks in participants aged ≥9 years (≥12 years, phase-2) with moderate-to-severe acne. RESULTS: A total of 2029 participants (tazarotene 0.045% lotion or vehicle) were included across the 5 studies (safety populations:  = 1982). In the phase-1 studies, tazarotene had a low potential for irritancy/contact dermatitis and did not induce sensitization. In all studies, tazarotene lotion was well tolerated and had a positive safety profile. In addition, tazarotene lotion reduced the severity of hyperpigmentation and erythema and participants preferred it more than previous acne treatments. CONCLUSIONS: The results from these five studies show that the tolerability, safety, and patient satisfaction of topical tazarotene 0.045% lotion, combined with its efficacy, make it an important option for the treatment of acne.

Department

Dermatology

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