Efficacy and Safety of Tazarotene Lotion, 0.045% in the Treatment of Truncal Acne Vulgaris

July 2022 | Volume 21 | Issue 7 | 713 | Copyright © July 2022


Published online June 30, 2022

Leon H. Kircik MD

Icahn School of Medicine at Mount Sinai, New York, NY; Indiana University Medical Center, Indianapolis, IN;
Physicians Skin Care, PLLC Louisville, KY; DermResearch, PLLC Louisville, KY; Skin Sciences, PLLC Louisville, KY

Abstract
Background: Although truncal acne is thought to have the same pathophysiology as facial acne, treatment response may differ based on body area involvement. Traditionally, prescribers have relied on oral therapies for the management of truncal acne, possibly because oral therapy has been considered more convenient than topical application of medication to the chest and back. A lotion formulation may be particularly well-suited for the treatment of truncal acne. Tazarotene lotion, 0.045% is FDA approved for treatment of acne vulgaris in individuals 9 years of age or older. This pilot study was designed to investigate the efficacy and safety of Arazlo lotion for the treatment of truncal acne.
Study Findings: A total of 19 subjects ranging in age from 12 to 58 years completed the 12-week study. There were significant reductions in truncal IGA (the primary endpoint) at each of the study follow-up visits. At week 12, 89% of subjects were clear or almost clear, as assessed by truncal IGA score. There were statistically significant reductions in inflammatory, non-inflammatory, and total lesion counts from baseline to week 12. Treatment with tazarotene lotion 0.045% was well-tolerated, with erythema, dryness, peeling, oiliness, pruritis, and burning generally rated as trace or mild. Most subjects (64% or more) rated the lotion as “Good” or “Excellent” in general and in comparison to their prior medications.
Conclusions: Tazarotene lotion, 0.045% is shown to be effective and well-tolerated for the management of truncal acne in this pilot study. Further studies with placebo control and larger populations are warranted.

J Drugs Dermatol. 2022;21(7):713-716. doi:10.36849/JDD.6967

INTRODUCTION

It is estimated that more than half of all individuals with acne have truncal involvement. Truncal acne is thought to have the same pathophysiology as facial acne. However, a recent review determined that treatment response may differ based on body area involvement.1 Despite the prevalence of truncal acne, patients may not bring involvement of the chest, back, or shoulders to the attention of their physicians.2 Of note, the presence of facial and truncal acne has been found to be associated with a greater impact on health-related quality of life (HRQoL) than facial acne alone. In fact, as severity of truncal acne increases, the adverse impact on HRQoL increases, regardless of the severity of facial acne.3

Truncal acne can result in scarring and pigmentary alteration. Therefore, implementation of early, effective treatment is encouraged.2

Traditionally, prescribers have relied on oral therapies for the management of truncal acne,4 possibly because oral therapy has been considered more convenient than topical application of medication to the chest and back. More recently, dermatologists have been encouraged to reduce reliance on oral antibiotics with the goal to reduce risks for developing bacterial resistance.

A lotion formulation may be particularly well-suited for the topical treatment of truncal acne and may enhance the convenience of topical treatment. In the phase 3 trials for tazarotene lotion (Arazlo®), 0.045%, subjects with truncal acne used the investigational treatment on the chest and back. However, efficacy for truncal acne was not assessed as a study endpoint. Arazlo is now FDA approved for treatment of acne vulgaris in individuals 9 years of age or older. This pilot study was designed to investigate the efficacy and safety of tazarotene lotion, 0.045% for the treatment of truncal acne.

SUBJECT SELECTION AND DEMOGRAPHICS

Outpatient, male or female subjects of any race, and at least 9 years of age with truncal acne IGA of 3 (Moderate severity) were eligible for enrollment. Female subjects of childbearing potential were required to have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.