Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

Study Overview
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Brief Summary
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Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Tazarotene Cream 0.1%
* Drug: Adapalene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater). Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study. Exclusion Criteria: Non-compliance with washout period Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris Allergy or sensitivity to any component of the test medications Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

Ages Eligible for Study
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Minimum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tazarotene Cream 0.1%<br>1 pea-size amount, QD x 16 weeks | Drug: Tazarotene Cream 0.1%<br>* 1 pea-size amount, QD x 16 weeks<br>* Other names: TAZORAC® Cream 0.1%;|
| Active Comparator: Adapalene Gel 0.3%<br>1 pea-size amount, QD x 16 weeks | Drug: Adapalene<br>* 1 pea-size amount, QD x 16 weeks<br>* Other names: Differin® Gel 0.3%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement). | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 | Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. | Week 16 | 
| Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 | Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne. | Week 12 | 
| Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 | Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). | Baseline, Week 16 |