Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

Study Overview
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Brief Summary
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This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.

Official Title
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A Multicenter, Randomized, Double-blinded, Active-controlled Parallel Group Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: GK530G
* Drug: CD0271
* Drug: CD1579


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: GK530G<br>Fixed-dose combination gel of Adapalene and Benzoyl Peroxide | Drug: GK530G<br> <br> * Other names: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide;|
| Active Comparator: CD0271<br>Adapalene 01% Gel | Drug: CD0271<br> <br> * Other names: Adapalene 0.1% Gel;|
| Active Comparator: CD1579<br>Benzoyl Peroxide 2.5% Gel | Drug: CD1579<br> <br> * Other names: Benzoyl Peroxide 2.5% Gel;|

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 |  | Baseline - Week12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With Adverse Events |  | 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