Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel

• Status: Completed
• Trial end date: 2018-02-08
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the long-term safety of once-daily application of Omiganan topical 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 nonpregnant female subjects, 18 years of age or older.

2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline

3. Subjects with the presence of telangiectasia at Baseline

4. Subjects with the presence of facial erythema associated with their rosacea at Baseline

Exclusion Criteria:

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

2. Subjects with nodular rosacea

3. Standard exclusion criteria.