A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis

• Status: Completed
• Trial end date: 2017-08-02
• Target enrollment: 0
• Participant gender: All

Summary

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fougera Pharmaceuticals Inc.
• Treatments: Nicotinic Acids; Tazarotene

Criteria

Inclusion Criteria:

• Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)

• Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion

• Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Exclusion Criteria:

• A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period

• Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis

• Have a history of psoriasis unresponsive to topical treatments