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Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study.

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.
AuthorsA R Shalita, D K Chalker, R F Griffith, A A Herbert, J G Hickman, J M Maloney, B H Miller, E H Tschen, R A Chandraratna, J R Gibson, D A Lew-Kaya, J C Lue, J Sefton
JournalCutis (Cutis) Vol. 63 Issue 6 Pg. 349-54 (Jun 1999) ISSN: 0011-4162 [Print] United States
PMID10388959 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Gels
  • Keratolytic Agents
  • Nicotinic Acids
  • Retinoids
  • tazarotene
Topics
  • Acne Vulgaris (drug therapy)
  • Adolescent
  • Adult
  • Double-Blind Method
  • Female
  • Gels (administration & dosage, adverse effects)
  • Humans
  • Keratolytic Agents (administration & dosage, adverse effects)
  • Male
  • Nicotinic Acids (administration & dosage, adverse effects, pharmacokinetics)
  • Patient Satisfaction
  • Retinoids (administration & dosage, adverse effects)
  • Time Factors
  • Treatment Outcome

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