The safety and efficacy of tazarotene gel, a topical acetylenic retinoid, in the treatment of psoriasis.

OBJECTIVE

To determine the safety and efficacy of topically applied tazarotene gel in the treatment of mild to moderate psoriatic plaques.

DESIGN

Two multicenter, double-blind, randomized studies of 6- and 8-week duration, with an 8-week follow-up in the second study.

SETTING

Medical center outpatient dermatology services.

PARTICIPANTS

One hundred fifty-three adults with 2 bilateral target plaques on the trunk, legs, or arms.

INTERVENTIONS

Vehicle gel or 0.01% and 0.05% tazarotene gel administered twice daily to 45 patients (study A), or 0.05% and 0.1% tazarotene gel administered either once or twice daily to 108 patients (study B).

MAIN OUTCOME MEASURES

Treatment success and plaque elevation, scaling, and erythema vs time.

RESULTS

The 0.01% tazarotene gel showed minimal efficacy. Applications of 0.05% and 0.1% tazarotene gels administered once or twice daily, resulted in significant improvements in plaque elevation, scaling, erythema, and overall clinical severity as early as 1 week. Treatment success rates (defined as > 75% improvement from baseline) were 45% with 0.05% tazarotene gel vs 13% with vehicle gel after 6 weeks of treatment (P < .05; study A) and ranged from 48% to 63% with the various tazarotene treatment regimens after 8 weeks of treatment (study B). These improvements were evident at the 8-week follow-up. Treatment-related adverse effects were generally limited to mild or moderate local irritation and were less frequent with the treatment regimen administered once daily.

CONCLUSION

The 0.05% and 0.1% tazarotene gels demonstrated significant efficacy in the treatment of mild to moderate psoriatic plaques that persisted after cessation of treatment.