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

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.

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.