CONTEXT: Short-contact application of 0.1% tazarotene gel for acne was devised to minimize local adverse effects. Its efficacy and safety are unknown. OBJECTIVES: To assess acne improvement and tolerability during 12 weeks of short-contact treatment with 0.1% tazarotene gel vs a nonmedicated gel control. DESIGN: A randomized, masked, vehicle-controlled trial. SETTING:Outpatient facilities at an urban medical school and an affiliated suburban office practice. PARTICIPANTS: Ninety-nine volunteers with facial acne were enrolled; 81 completed the study. INTERVENTION: Thirty-three patients were randomly assigned to each of 3 groups: T + T applied 0.1% tazarotene gel twice daily, T + V applied 0.1% tazarotene gel once daily and vehicle gel once daily, and V + V applied vehicle gel twice daily. Patients adjusted the contact period as tolerated, between 30 seconds and 5 minutes per application. MAIN OUTCOME MEASURES: Acne efficacy by reduction in acne lesions, treatment success (50%-100% improvement in global response to treatment) and improvement in overall disease severity. Local adverse effects, scored from none to severe. RESULTS: By week 12, T + T and T + V achieved significantly greater improvement in acne than V + V based on mean percentage reduction in noninflammatory lesions (46% and 41% vs 2%; P =.002) and inflammatory lesions (38% and 34% vs 9%; P =.01), percentage of treatment successes (64% and 61% vs 15%; P<.001), and reduction in overall disease severity (30% and 29% vs 3%; P<.001). Local adverse effects did not differ significantly among the 3 groups after week 4. CONCLUSION: Short-contact 0.1% tazarotene gel therapy is a safe and effective new method of acne treatment.
RCT Entities:
CONTEXT: Short-contact application of 0.1% tazarotene gel for acne was devised to minimize local adverse effects. Its efficacy and safety are unknown. OBJECTIVES: To assess acne improvement and tolerability during 12 weeks of short-contact treatment with 0.1% tazarotene gel vs a nonmedicated gel control. DESIGN: A randomized, masked, vehicle-controlled trial. SETTING:Outpatient facilities at an urban medical school and an affiliated suburban office practice. PARTICIPANTS: Ninety-nine volunteers with facial acne were enrolled; 81 completed the study. INTERVENTION: Thirty-three patients were randomly assigned to each of 3 groups: T + T applied 0.1% tazarotene gel twice daily, T + V applied 0.1% tazarotene gel once daily and vehicle gel once daily, and V + V applied vehicle gel twice daily. Patients adjusted the contact period as tolerated, between 30 seconds and 5 minutes per application. MAIN OUTCOME MEASURES: Acne efficacy by reduction in acne lesions, treatment success (50%-100% improvement in global response to treatment) and improvement in overall disease severity. Local adverse effects, scored from none to severe. RESULTS: By week 12, T + T and T + V achieved significantly greater improvement in acne than V + V based on mean percentage reduction in noninflammatory lesions (46% and 41% vs 2%; P =.002) and inflammatory lesions (38% and 34% vs 9%; P =.01), percentage of treatment successes (64% and 61% vs 15%; P<.001), and reduction in overall disease severity (30% and 29% vs 3%; P<.001). Local adverse effects did not differ significantly among the 3 groups after week 4. CONCLUSION: Short-contact 0.1% tazarotene gel therapy is a safe and effective new method of acne treatment.
Authors: Yuka Asai; Akerke Baibergenova; Maha Dutil; Shannon Humphrey; Peter Hull; Charles Lynde; Yves Poulin; Neil H Shear; Jerry Tan; John Toole; Catherine Zip Journal: CMAJ Date: 2015-11-16 Impact factor: 8.262