Clinical safety of tazarotene in the treatment of plaque psoriasis.

Oral retinoids are effective in the treatment of psoriasis, but their use is limited by concerns for teratogenic potential and systemic side effects. Tazarotene is a novel acetylenic retinoid undergoing clinical trials for the topical treatment of mild-to-moderate plaque psoriasis. The safety and tolerability of tazarotene 0.1% and 0.05% gels were examined in a series of preclinical and clinical trials. In preclinical studies topically applied tazarotene gel was nonmutagenic, noncarcinogenic, and nonteratogenic. Tazarotene gel was not sensitizing, phototoxic, or photosensitizing in a series of studies in human volunteers. Treatment-related systemic adverse effects were not observed in clinical trials involving approximately 2000 patients treated with tazarotene 0.1% or 0.05% gel for periods of up to 1 year. Adverse effects appear limited to manageable, mainly mild-to-moderate local skin irritation.