A Study Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.

Study Overview
=================
Brief Summary
-----------------
To evaluate the therapeutic equivalence and safety of halobetasol propionate and tazarotene topical lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (halobetasol and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the treatment of moderate to severe plaque psoriasis.

Detailed Description
-----------------
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe Plaque Psoriasis.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) and Both Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%
* Drug: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 18 years Subjects must have provided IRB approved written informed consent Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits Subjects with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving at least 3% and no more than 12% of the body surface area (BSA). Affected areas should not include the axillae, face, scalp, soles, palms, and intertriginous areas Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. Females of childbearing potential who do not agree to utilize an adequate form of contraception. Subjects with a known hypersensitivity to tazarotene, halobetasol propionate, other corticosteroids, or to any ingredients in the study drugs. Subjects with current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045%<br>The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks | Drug: Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045%<br>* The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks.<br>* Other names: Test Product;|
| Active Comparator: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%<br>The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks | Drug: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%<br>* The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks.<br>* Other names: Reference Product;|
| Placebo Comparator: Placebo Control<br>The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks | Drug: Placebo<br>* The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks.<br>* Other names: Vehicle;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects with a response of treatment success on the IGA of disease severity at Week 8 |  | Week 8 |