Effects of tazarotene 0.1 % cream in the treatment of facial acne vulgaris: pooled results from two multicenter, double-blind, randomized, vehicle-controlled, parallel-group trials.

ABSTRACT

BACKGROUND: Topical retinoids are one of the most effective classes of topical drugs used to treat acne vulgaris. The effects of the gel formulation of the topical retinoid tazarotene have been widely reported, but few data on the cream formulation are available. OBJECTIVE: The primary aim of the 2 studies reported in this article was to determine the effects of tazarotene 0.1 % cream in patients with facial acne vulgaris. METHODS: Two randomized, double-blind, parallel-group studies were performed. The first was conducted at 14 investigational sites across the United States, and the second took place at 15 sites, with 5 of these providing blood samples for analysis of tazarotenic acid. In both studies, patients aged > or =12 years with facial acne vulgaris were randomized to receive tazarotene or vehicle cream QD for 12 weeks. Lesion counts (noninflammatory, inflammatory, and total) and overall clinical and global assessments were made at weeks 0 (baseline), 4, 8, and 12. Adverse events (AEs) were monitored throughout the study In one of the studies, therapeutic drug monitoring was performed at weeks 4 and 8 in members of the study population who gave consent for blood withdrawal. RESULTS: Eight hundred forty-seven patients were enrolled in the 2 studies (430 males, 417 females; mean age,19 years; age range, 11-52 years [1 patient was entered into the study at age 11 years, in violation of the protocol]). At 12 weeks, the median percentage changes from baseline in all 3 lesion counts were significantly lower with tazarotene than with vehicle (all, P < 0.001), as were the overall clinical and global responses (both, P < 0.001). Treatment-related AEs whose incidence was higher with tazarotene than with vehicle included desquamation, dry skin, erythema, a burning sensation on the skin, and skin irritation (all, P < 0.001) and pruritus (P < 0.01); most (83%-98%) were mild or moderate. Systemic exposure to tazarotenic acid was limited (mean, <0.1 ng/mL) and did not increase with time. CONCLUSIONS: In these 2 studies in adolescent and adult patients with facial acne vulgaris, tazarotene 0.1%cream QD for 12 weeks was effective and well tolerated. Systemic exposure to tazarotenic acid was limited.