1. Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study.
- Author
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Shalita AR, Chalker DK, Griffith RF, Herbert AA, Hickman JG, Maloney JM, Miller BH, Tschen EH, Chandraratna RA, Gibson JR, Lew-Kaya DA, Lue JC, and Sefton J
- Subjects
- Adolescent, Adult, Double-Blind Method, Female, Gels administration & dosage, Gels adverse effects, Humans, Keratolytic Agents adverse effects, Male, Nicotinic Acids adverse effects, Nicotinic Acids pharmacokinetics, Patient Satisfaction, Retinoids adverse effects, Time Factors, Treatment Outcome, Acne Vulgaris drug therapy, Keratolytic Agents administration & dosage, Nicotinic Acids administration & dosage, Retinoids administration & dosage
- Abstract
Retinoids reverse the abnormal pattern of keratinization seen in acne vulgaris. Tazarotene is the first of a novel family of topical receptor-selective acetylenic retinoids. This study evaluates the safety and efficacy of topical tazarotene 0.1% and 0.05% gels, in comparison to vehicle gel, applied once daily for 12 weeks, in the treatment of mild-to-moderate facial acne vulgaris. A total of 446 patients with facial acne vulgaris were enrolled, and 375 patients, ranging in age from 14 to 44 years, were evaluable in this multicenter, double-blind, randomized study. In comparison to vehicle gel, treatment with tazarotene 0.1% gel resulted in significantly greater reductions in noninflammatory and total lesion counts at all follow-up visits, and inflammatory lesion counts at Week 12. Tazarotene 0.05% gel resulted in significantly greater reductions in noninflammatory and total lesion counts than vehicle gel at Weeks 8 and 12. At Week 12, treatment success rates were 68% and 51% for tazarotene 0.1% and 0.05%, respectively (40% for vehicle gel). Tazarotene gel was an effective, safe, and generally well-tolerated therapy for the treatment of acne vulgaris.
- Published
- 1999