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:	4/17/2018
Start Date:	October 2015
End Date:	September 5, 2017

A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period

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 Fort Smith Arkansas

Fort Smith, Arkansas 72901

from

Fort Smith, AR