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.