Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Detailed Description
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This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Official Title
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A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of Adapalene Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene lotion 0.1%
* Drug: Adapalene Lotion Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Moderate or Severe Acne Vulgaris, 20-50 papules and pustules in total on the face excluding the nose 30-100 non-inflammatory lesions on the face excluding the nose. Negative urine pregnancy test for all females. Exclusion Criteria: Subjects with more than one acne nodule. Subjects with any acne cyst on the face. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. Subjects who are pregnant, nursing, or planning a pregnancy.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapalene lotion 0.1%<br> | Drug: Adapalene lotion 0.1%<br>* Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks<br>|
| Placebo Comparator: Adapalene Lotion vehicle<br> | Drug: Adapalene Lotion Vehicle<br>* Vehicle will be applied topically to the face, once a day, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 | Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe. | From Baseline to Week 12 | 
| Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 |  | Baseline to 12 weeks | 
| Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 |  | Baseline to Week 12 | 
| Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Percent change in lesion count from baseline to week 12 | From Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Adapalene