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

Phase 3

Completed

• Conditions: Rosacea
• Interventions: Drug: Omiganan

• Registration Number: NCT02576847
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Primary Completion: 2017-07-14
• Study Completion: 2018-02-08
• Disposition First Submitted: 2018-07-13
• Disposition First Submitted QC: 2018-07-13
• Disposition First Posted: 2018-07-18
• Results First Submitted: 2022-06-13
• Results First Submitted QC: 2022-06-13
• Status Verified: 2022-07
• Results First Posted: 2022-07-06
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Omiganan	Omiganan gel applied once daily

Primary Outcome Measures

Name	Time	Method
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events	Up to 12 months	Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events