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

• Status: Completed
• Trial end date: 2018-04-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.

Criteria

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.