Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
| Status: | Completed |
|---|---|
| Conditions: | Acne, Acne, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
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
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
topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel
in subjects with inflammatory acne vulgaris
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
We found this trial at
20
sites
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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