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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
866
Tazarotene Cream, 0.05% (G \& W Laboratories, Inc.)
Vehicle of Test product (G \& W Laboratories, Inc.)
Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)
Altman Dermatology Associates
Arlington Heights, Illinois, United States
primary efficacy endpoint
The primary efficacy endpoint is the proportion of subjects with treatment success on the IGA at Visit 4/Week 12. Treatment success is defined as absent, very mild, or mild disease shown by a score of 0, 1, or 2 within the treatment area on the IGA. The primary analyses include evaluation of bioequivalence between the 2 active products and evaluations of superiority of each active treatment over the vehicle.
Time frame: Week 12
Proportion of subjects with disease severity
Secondary efficacy endpoints will include: 1) the proportion of subjects with disease severity at Visit 4/Week 12 consistent with absent or very mild disease shown by a score of 0 or 1 within the treatment area on the IGA
Time frame: Week 12
the proportion of subjects with target lesion site
the proportion of subjects with target lesion site plaque elevation, scaling, and erythema scores of ≤ 1 on the PASI at Visit 4/Week 12.
Time frame: Week 12
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