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 |
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.
(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
We found this trial at
29
sites
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