Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

Official Title
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Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne

Conditions
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Acne

Intervention / Treatment
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* Drug: Epiduo vehicle gel
* Drug: CD07223
* Drug: CD07223
* Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject has a clinical diagnosis of acne vulgaris with facial involvement the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face Exclusion Criteria: subject has a severe acne form or secondary acne form the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face the subject has a known allergy or sensitivity to any of the components of the study products subject is not willing to respect wash-out periods for topical and/or systemic treatments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Experimental: CD07223 1.5% gel<br>500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face | Drug: Epiduo vehicle gel<br>* 500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks<br>Drug: CD07223<br>* 500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks<br>|
| Experimental: CD07223 0.5% gel<br>500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face | Drug: Epiduo vehicle gel<br>* 500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks<br>Drug: CD07223<br>* 500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks<br>|
| Active Comparator: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel<br>500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces | Drug: Epiduo vehicle gel<br>* 500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks<br>Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel<br>* 500 microliters Epiduo Gel on one of the half-face for the morning dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total acne lesion count | change in total number of acne lesion count from baseline to end of treatment | 6 weeks | 
| Percent change of acne lesion count | Percent change of acne lesion count from baseline to end of treatment | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion counts- Inflammatory | change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject | 6 weeks | 
| Lesion count- non-inflammatory | change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject | 6 weeks | 
| Lesion counts- Inflammatory | Percent change of acne lesion count from baseline at each evaluation visit | 6 weeks | 
| Lesion count- non-inflammatory | Percent change of acne lesion count from baseline at each evaluation visit | 6 weeks |