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

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: n = 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.

Keywords:

• Topical
• retinoid
• tazarotene
• safety

Acknowledgments

The medical writing support was provided by Jacqueline Benjamin, Ph.D. and Lynn M. Anderson, Ph.D. of Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics.

Disclosure statement

Leon Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Lawrence Green has served as investigator, consultant, or speaker for: Almirall, Cassiopea, Galderma, Ortho Dermatologics, Sol Gel, Sun Pharma, and Vyne. Eric Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company. Waleed Khalid, and Binu Alexander are employees of Bausch Health US, LLC and may hold stock and/or stock options in its parent company. Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Additional information

Funding

The present work was financially supported by Ortho Dermatologics.