Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

Status:	Completed
Conditions:	Cosmetic
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	18 - Any
Updated:	7/12/2018
Start Date:	October 2015
End Date:	April 13, 2018

A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel
compared to vehicle gel in subjects with severe papulopustular rosacea.

Inclusion Criteria:

1. Healthy, male and non-pregnant female subjects, 18 years of age or older.

2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

3. Subjects with the presence of telangiectasia at Baseline.

4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
Erythema scale at Baseline.

5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

2. Subjects with nodular rosacea.

3. Standard exclusion criteria.

We found this trial at

sites

Clinical Trial Facility in Miami Florida

Miami, Florida 33136

from

Miami, FL