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A 12-Month Multicenter, Randomized Trial

Tania J. Phillips, MD; Alice B. Gottlieb, MD, PhD; James J. Leyden, MD; Nicholas J. Lowe, MD; Deborah A. Lew-Kaya, PharmD; John Sefton, PhD; Patricia S. Walker, MD, PhD; John R. Gibson, MD; and the Tazarotene Cream Photodamage Clinical Study Group

Arch Dermatol. 2002;138:1486-1493.

Objective  To determine the efficacy and safety of 0.1% tazarotene cream for the treatment of photodamage.

Design  A 24-week multicenter, double-blind, randomized, vehicle-controlled intervention study followed by a 28-week open-label extension.

Setting  Ambulatory patients in private and institutional practice.

Patients  Of 563 patients with facial photodamage, 91% and 86% completed the double-blind and open-label phases, respectively. In the double-blind phase, 20 of 283 tazarotene-treated patients and 1 of 280 vehicle-treated patients discontinued treatment owing to adverse events.

Intervention  Once-daily application of 0.1% tazarotene cream or nonmedicated vehicle cream to the face for 24 weeks. Then, all continuing patients received treatment with 0.1% tazarotene cream for another 28 weeks.

Main Outcome Measures  Primarily, fine wrinkling and mottled hyperpigmentation. Also, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, telangiectasia, actinic keratoses, overall integrated assessment of photodamage, global response to treatment, patients' overall assessment of photodamage, and plasma levels of tazarotenic acid.

Results  Compared with the vehicle, at week 24 tazarotene resulted in a significantly greater incidence of patients achieving treatment success (50% global improvement) and at least a 1-grade improvement in fine wrinkling, mottled hyperpigmentation, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, and the overall integrated assessment of photodamage (P<.01). Additional clinical improvement occurred with continued tazarotene treatment and had not plateaued by week 52. Plasma tazarotenic acid concentrations did not exceed 0.71 ng/mL.

Conclusions  Once-daily applications of 0.1% tazarotene cream significantly reduced multiple signs of photodamage. Plasma levels of tazarotenic acid remained below those of endogenous retinoids.

From Boston University School of Medicine, Boston, Mass (Dr Phillips); University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick (Dr Gottlieb); University of Pennsylvania Hospital, Philadelphia (Dr Leyden); Clinical Research Specialists, Santa Monica, Calif (Dr Lowe); and Allergan, Inc, Irvine, Calif (Drs Lew-Kaya, Sefton, Walker, and Gibson).

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