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

Completed · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT02886702

Run by

Fougera Pharmaceuticals Inc.

People needed

855

Starts

2016-09-19

Expected to finish

2017-08-02

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Fougera Investigational Site — Phoenix, Arizona, United States
• Fougera Investigational Site — Hot Springs, Arkansas, United States
• Fougera Investigational Site — Anaheim, California, United States
• Fougera Investigational Site — North Hollywood, California, United States
• Fougera Investigational Site — San Diego, California, United States
• Fougera Investigational Site — San Ramon, California, United States
• Fougera Investigational Site — Brandon, Florida, United States
• Fougera Investigational Site — Coral Gables, Florida, United States
• Fougera Investigational Site — Hialeah, Florida, United States
• Fougera Investigational Site — Miami, Florida, United States
• Fougera Investigational Site — Miami, Florida, United States
• Fougera Investigational Site — Miami, Florida, United States
• Fougera Investigational Site — Miami Gardens, Florida, United States
• Fougera Investigational Site — Miramar, Florida, United States
• Fougera Investigational Site — Sweetwater, Florida, United States
• Fougera Investigational Site — Tampa, Florida, United States
• Fougera Investigational Site — West Palm Beach, Florida, United States
• Fougera Investigational Site — Macon, Georgia, United States
• Fougera Investigational Site — Arlington Heights, Illinois, United States
• Fougera Investigational Site — New Albany, Indiana, United States
• Fougera Investigational Site — Plainfield, Indiana, United States
• Fougera Investigational Site — Louisville, Kentucky, United States
• Fougera Investigational Site — Lake Charles, Louisiana, United States
• Fougera Investigational Site — Saint Joseph, Missouri, United States
• Fougera Investigational Site — Henderson, Nevada, United States

Full record on ClinicalTrials.gov

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