Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

Study Overview
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Brief Summary
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This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

Official Title
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A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CD1579 2.5%
* Drug: CD1579 5%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women at the age of 12 or older at the Screening visit. Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin). Exclusion Criteria: Those with more than two nodular acne lesions or any cysts. Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne. Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD1579 2.5%<br>Benzoyl Peroxide 2.5% | Drug: CD1579 2.5%<br> <br> * Other names: Benzoyl Peroxide 2.5%;|
| Experimental: CD1579 5%<br>Benzoyl Peroxide 5% | Drug: CD1579 5%<br> <br> * Other names: Benzoyl Peroxide 5%;|
| Placebo Comparator: Vehicle<br>Vehicle | Drug: Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Changes From Baseline in Total Lesion Counts | Median percent reductions from Baseline in total lesion count (ITT-LOCF) | Baseline - Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With Adverse Events | Adverse events which were observed in 5% or more patients with either group are listed. | up to 12 weeks | 
| Local Tolerability (Erythema) | Highest severity of local tolerability scores worse than Baseline | 12 weeks | 
| Local Tolerability (Scaling) | Highest severity of local tolerability scores worse than Baseline | 12 weeks | 
| Local Tolerability (Dryness) | Highest severity of local tolerability scores worse than Baseline | 12 weeks | 
| Local Tolerability (Pruritus) | Highest severity of local tolerability scores worse than Baseline | 12 weeks | 
| Local Tolerability (Stinging/Burning) | Highest severity of local tolerability scores worse than Baseline | 12 weeks | 

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