A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris



Status:Recruiting
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:October 2015
End Date:November 2016
Contact:Laura Epelbaum
Email:l.epelbaum@prosoftclinical.com

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A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris

The primary objective of this study is to evaluate the safety and efficacy of Omiganan
(CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in
female subjects with moderate to severe inflammatory acne vulgaris.


Inclusion Criteria:

- Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris

- Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of
Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.

- Subjects with ≥ 30 facial inflammatory lesions

Exclusion Criteria:

- Subjects with < 10 or > 75 facial non-inflammatory lesions

- Subjects with > 3 facial nodular or cystic lesions at Baseline

- Standard exclusion criteria
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