Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris

Official Title
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A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CLS001 Topical Gel
* Drug: CLS001 Topical Gel Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older. Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules. An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4) Exclusion Criteria: Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.) Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose) Subjects with more than 2 facial nodulocystic lesions

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 |
| --- | --- |
| Placebo Comparator: Vehicle Gel<br> | Drug: CLS001 Topical Gel Vehicle<br> <br> |
| Experimental: CLS001 topical gel 1%<br>Topical application once daily | Drug: CLS001 Topical Gel<br> <br> |
| Experimental: CLS001 topical gel 1.75%<br>Topical application once daily | Drug: CLS001 Topical Gel<br> <br> |
| Experimental: CLS001 topical gel 2.5%<br>Topical application once daily | Drug: CLS001 Topical Gel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory lesion count from Baseline |  | 6, 9 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions |  | 1, 3, 6, 9 and 12 weeks | 
| Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions |  | 1, 3, 6, 9 and 12 weeks | 
| Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit |  | 1, 3, 6, 9, and 12 weeks | 
| Percentage of subjects with a 2 grade reduction in the IGA at each visit |  | 1, 3, 6, 9, and 12 weeks |