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

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

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