Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study.
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.
Shalita
A R
AR
Department of Dermatology, Downstate Medical Center, Brooklyn, State University of New York 11203, USA.
Chalker
D K
DK
Griffith
R F
RF
Herbert
A A
AA
Hickman
J G
JG
Maloney
J M
JM
Miller
B H
BH
Tschen
E H
EH
Chandraratna
R A
RA
Gibson
J R
JR
Lew-Kaya
D A
DA
Lue
J C
JC
Sefton
J
J
D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005782:Gels / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009539:Nicotinic Acids / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D017060:Patient Satisfaction; D012176:Retinoids / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D005782:Gels; D007641:Keratolytic Agents; D009539:Nicotinic Acids; D012176:Retinoids; C086827:tazarotene