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A Multicenter, Investigator-Masked, Randomized, Vehicle-Controlled, Parallel Comparison of 0.01%, 0.025%, 0.05%, and 0.1% Tazarotene Creams With 0.05% Tretinoin Emollient Cream Applied Once Daily for 24 Weeks

Sewon Kang, MD; James J. Leyden, MD; Nicholas J. Lowe, MD; Jean-Paul Ortonne, MD; Tania J. Phillips, MD; Gerald D. Weinstein, MD; Jag Bhawan, MD; Deborah A. Lew-Kaya, PharmD; Richard M. Matsumoto, PhD; John Sefton, PhD; Patricia S. Walker, MD, PhD; John R. Gibson, MD

Arch Dermatol. 2001;137:1597-1604.

Objective  To assess the safety and efficacy of 4 concentrations of tazarotene cream in the treatment of facial photodamage.

Design  Prospective weekly multicenter, investigator-masked, randomized, parallel-group study.

Setting  University hospitals and clinical research centers.

Patients  Three hundred forty-nine subjects with facial photodamage.

Intervention  Daily topical application of tazarotene cream (0.01%, 0.025%, 0.05%, and 0.1%) compared with its vehicle and with 0.05% tretinoin emollient cream.

Results  Tazarotene cream and tretinoin cream significantly improved mottled hyperpigmentation and fine wrinkles. At week 24, treatment success rates based on global responses were 67% (39 of 58 subjects) with 0.1% tazarotene, 52% (30 of 58 subjects) with 0.05% tazarotene, 36% (21 of 58 subjects) with 0.025% tazarotene, 41% (24 of 59 subjects) with 0.01% tazarotene, 55% (32 of 58 subjects) with 0.05% tretinoin, and 22% (13 of 58 subjects) with vehicle. Local adverse events, although more frequent with tazarotene at higher concentrations, were generally mild to moderate.

Conclusions  Tazarotene in a cream formulation is safe and is associated with positive changes in the treatment of photodamaged facial skin.

From the Department of Dermatology, University of Michigan Medical Center, Ann Arbor (Dr Kang); the Skin Study Center, Broomall, Pa (Dr Leyden); Clinical Research Specialists, Santa Monica, Calif (Dr Lowe); Hôpital de l'Archet, Nice, France (Dr Ortonne); Department of Dermatology, Boston University Medical Center, Boston, Mass (Drs Phillips and Bhawan); Department of Dermatology, the University of California, Irvine (Dr Weinstein); and Allergan, Inc, Irvine, Calif (Drs Lew-Kaya, Matsumoto, Sefton, Walker, and Gibson). Drs Kang, Leyden, Lowe, and Weinstein have served as paid consultants to Allergan, Inc. Dr Leyden also has been compensated for his participation in clinical trials, in advisory boards, and as a member of a speakers' bureau for Allergan, Inc. Dr Lowe also has received research grants from and has stock ownership in Allergan, Inc.

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