NCT02160665

Generic Tazarotene Cream, 0.05% for the Treatment of Plaque Psoriasis

A Double-Blind,Randomized,Parallel-Group,Vehicle-Controlled,Multi-Center Study Comparing a Generic Tazarotene Cream, 0.05% to RLD Tazorac® Cream, 0.05% and Both Treatments to a Vehicle in the Treatment of Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 866 (actual)
• Sponsor: G & W Laboratories Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety and efficacy profiles of Tazarotene Cream, 0.05% and Tazorac® (Tazarotene) Cream, 0.05% in order to demonstrate bioequivalence and to demonstrate the superiority of the 2 active creams over that of the Vehicle (placebo) in the treatment of plaque psoriasis.

Detailed description

This is a double-blind, randomized, parallel-group, vehicle-controlled, multicenter study of Tazarotene Cream, 0.05% in subjects with plaque psoriasis. Subjects will be randomly assigned in a 1:1:1 ratio to Test, Reference, or Vehicle. Subjects will be admitted into the study after informed consent has been obtained and all inclusion/exclusion criteria have been met. At each visit, the same investigator (whenever possible) will grade the clinical signs of plaque psoriasis at the designated target lesion site using the Psoriasis Area Severity Index (PASI), an Investigator's Global Assessment (IGA) of disease severity will be performed (IGA scores range from 0 = none to 5 = very severe), and application site reactions (erythema, dryness, burning/stinging, erosion, edema, pain, and pruritus) will be assessed. In addition, the involved body surface area (BSA) will be determined at Visit 1 and Visit 4. Safety will be assessed by monitoring all adverse events (AEs) at each visit and a telephone contact at Day 7 (+ 4 days)

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Tazarotene Cream, 0.05%	Tazarotene Cream, 0.05% (G \& W Laboratories, Inc.)
DRUG	Vehicle	Vehicle of Test product (G \& W Laboratories, Inc.)
DRUG	Reference: Tazorac Cream, 0.05%	Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-06-11
• Last updated: 2016-11-03

Locations

1 site across 1 country: United States