Efficacy and Safety of Tazarotene 0.045% Lotion in Caucasian Adults With Moderate-to-Severe Acne
Del Rosso J, Stein Gold L, Tyring S, Zeichner J, Callender V, Draelos Z, Werschler W, Cook-Bolden F, and Guenin E. Efficacy and Safety of Tazarotene 0.045% Lotion in Caucasian Adults With Moderate-to-Severe Acne. J Drugs Dermatol 2022; 21(10):1061-1069.
Journal of drugs in dermatology
BACKGROUND: While topical retinoids are a mainstay of acne treatment, acne can manifest differently in various skin types. The objective of these post hoc analyses from two pooled phase 3 studies was to examine efficacy and safety of tazarotene 0.045% and quality of life improvements in self-identified Caucasian adults with moderate-to-severe acne.
METHODS: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion (N=1,614); a subset of adults (≥18 years) who self-reported Caucasian (White) race (n=645) were examined. Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment (endpoint) success (≥2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear]). Quality of life, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were also assessed.
RESULTS: At week 12, tazarotene lotion significantly reduced lesion counts by ~60% (least-squares mean percent changes from baseline, tazarotene vs vehicle: inflammatory, -61.2% vs -51.1%; noninflammatory, -59.7% vs -49.3%; P<0.001, both). Significantly more participants achieved treatment success with tazarotene lotion versus vehicle (P<0.001). Numerical improvements in quality-of-life domains were observed from baseline to week 12. Most TEAEs were unrelated to treatment, and rates of moderate-to-severe erythema decreased from baseline to week 12 with tazarotene treatment.
CONCLUSIONS: Tazarotene 0.045% lotion was efficacious and well tolerated over 12 weeks and led to quality-of-life improvements in Caucasian adults with moderate-to-severe acne. These results, along with those from patients with skin of color, demonstrate that once daily tazarotene 0.045% lotion is an effective and well-tolerated treatment option regardless of race or skin color.
Medical Subject Headings
Acne Vulgaris; Administration, Cutaneous; Adult; Dermatologic Agents; Double-Blind Method; Emollients; Emulsions; Humans; Nicotinic Acids; Quality of Life; Retinoids; Severity of Illness Index; Skin Cream; Treatment Outcome