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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Tazarotene Cream 0.05%
* Drug: TAZORAC® (tazarotene) Cream 0.05%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) | Drug: Tazarotene Cream 0.05%<br>* Tazarotene Cream 0.05% to cover only the lesions with a thin film.<br>* Other names: Tazarotene;|
| Active Comparator: Reference<br>TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) | Drug: TAZORAC® (tazarotene) Cream 0.05%<br>* TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.<br>* Other names: Tazarotene;|
| Placebo Comparator: Placebo<br>Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) | Drug: Placebo<br>* Placebo (vehicle of the test product) to cover only the lesions with a thin film.<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Assessed by IGA | Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the Investigator's Global Assessment of Disease Severity (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study). | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Severity None or Minimal on IGA | Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study). | Week 12 | 
| Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI | Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study). | Week 12 |