Tazarotene 0.045% Lotion for Females With Acne: Analysis of Two Adult Age Groups
Stein Gold L, Kircik L, Baldwin H, Callender V, Tanghetti E, Del Rosso J, Zeichner J, Cook-Bolden F, and Guenin E. Tazarotene 0.045% Lotion for Females With Acne: Analysis of Two Adult Age Groups. J Drugs Dermatol 2022; 21(6):587-595.
Journal of drugs in dermatology : JDD
BACKGROUND: Tapinarof cream 1% once daily, an aryl hydrocarbon receptor-modulating agent, was significantly more efficacious than vehicle and well tolerated in two 12-week phase 3 trials in adults with mild to severe plaque psoriasis.
OBJECTIVE: To assess long-term safety, efficacy, remittive effect, durability of response, and tolerability of tapinarof.
METHODS: Patients completing the 12-week trials were eligible for 40-weeks' open-label treatment and 4-weeks' follow-up. Treatment was based on Physician Global Assessment (PGA) score. Patients entering with PGA≥1 received tapinarof until PGA=0. Patients with PGA=0 discontinued tapinarof and were monitored for remittive effect. Patients with PGA≥2 were re-treated until PGA=0.
RESULTS: 91.6% (n=763) of eligible patients enrolled. 40.9% of patients achieved complete disease clearance (PGA=0) and 58.2% entering with PGA≥2 achieved PGA=0 or 1. Mean duration of remittive effect off-therapy for patients achieving PGA=0 was 130.1 days. No new safety signals were observed. Most frequent adverse events were folliculitis (22.7%), contact dermatitis (5.5%) and upper respiratory tract infection (4.7%).
LIMITATIONS: Open-label; no control; may not be generalizable to all forms of psoriasis; remittive effect/response rate potentially underestimated.
CONCLUSIONS: Efficacy improved beyond the 12-week trials, with a 40.9% complete disease clearance rate, ∼4-month off-therapy remittive effect, durability on therapy, and consistent safety.
Medical Subject Headings
Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Child; Dermatologic Agents; Double-Blind Method; Emollients; Emulsions; Excipients; Female; Humans; Nicotinic Acids; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome