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

Status:	Completed
Conditions:	Cosmetic
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	18 - Any
Updated:	7/20/2018
Start Date:	September 2015
End Date:	February 8, 2018

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea

This study evaluates the long-term safety of once-daily application of Omiganan topical gel
in subjects with severe papulopustular rosacea.

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.

We found this trial at

sites

Clinical Trial Facility in Miami Florida

Miami, Florida 33136

from

Miami, FL