Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The study hypothesis are based on the assumption that : CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: CD0271 0.3% / CD1579 2.5%
* Drug: CD0271 0.1% / CD1579 2.5%
* Drug: Topical Gel Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, who is 12 years of age or older at Screening visit. Clinical diagnosis of acne vulgaris with facial involvement. An IGA of Moderate (3) or Severe (4) at Baseline visit. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit. Exclusion Criteria: More than 2 acne nodules on the face at Baseline visit. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit The subject is unwilling to refrain from use of prohibited medication during the clinical trial. Use of hormonal contraceptives solely for control of acne.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD0271 0.3% /CD1579 2.5% Gel<br>active arm | Drug: CD0271 0.3% / CD1579 2.5%<br> <br> |
| Active Comparator: CD0271 0.1% / CD1579 2.5%<br>Comparator arm | Drug: CD0271 0.1% / CD1579 2.5%<br> <br> |
| Placebo Comparator: Topical Gel Vehicle<br>Placebo arm | Drug: Topical Gel Vehicle<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets. | Week 12 | 
| Changes From Baseline in Inflammatory Lesion Counts |  | Baseline - Week12 | 
| Changes From Baseline in Non-Inflammatory Lesion Counts |  | Baseline - Week 12 |