A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

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 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Official Title
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A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Tazarotene Cream 0.1%
* Drug: Tazorac®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face. Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment. Exclusion Criteria: Female subjects who are pregnant, nursing or planning to become pregnant during study participation. Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 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 0.1% (Fougera Pharmaceuticals Inc.) | Drug: Tazarotene Cream 0.1%<br>* Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.<br>* Other names: Tazarotene;|
| Active Comparator: Reference<br>TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) | Drug: Tazorac®<br>* Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.<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) applied to cover the affected areas of the face once daily for 84 +/- 4 days.<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inflammatory Lesion Counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | Week 12 | 
| Change in Non-inflammatory Lesion Counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response of Success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | Week 12 |