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

Maruho

Status and phase: Completed; Phase 3

Conditions: Rosacea

Treatments: Drug: Omiganan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576847

CLS001-CO-PR-006

Details and patient eligibility

About

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

Enrollment: 307 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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307 participants in 1 patient group

Treatment

Experimental group

Description:

Omiganan gel applied once daily

Treatment:

Drug: Omiganan