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Results of a Randomized Vehicle-Controlled Trial of Short-Contact Therapy With 0.1% Tazarotene Gel

Susan Bershad, MD; Giselle Kranjac Singer, BS; Janice E. Parente, PhD; Mei-Heng Tan, MD; Daniel W. Sherer, MD; Andrea N. Persaud, MD; Mark Lebwohl, MD

Arch Dermatol. 2002;138:481-489.

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.

From the Department of Dermatology, Mount Sinai School of Medicine, New York, NY (Drs Bershad, Tan, Sherer, Persaud, and Lebwohl and Ms Kranjac Singer); and Integrated Research Inc, Dollard-des-Ormeaux, Quebec (Dr Parente). Dr Bershad holds US patents and reserves all rights to international patents for the short-contact method of topical retinoid therapy to treat acne, photoaging, and psoriasis (patents 6017938, 6048902, 6083963, and 6096765). She has received compensation for speaking engagements from Allergan Inc, Irvine, Calif. Dr Parente is a co-owner and managing director of Integrated Research Inc, which has received compensation for clinical research consulting services from Allergan Inc. Dr Lebwohl has received research grants and compensation for speaking engagements from Allergan Inc.

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