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NCT02576847 Clinical Trial

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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02576847
Other study ID # CLS001-CO-PR-006
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2015
Est. completion date February 8, 2018

Study information
Verified date July 2022
Source Maruho Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 307
Est. completion date February 8, 2018
Est. primary completion date July 14, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Omiganan
Topical gel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Maruho Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Netherlands,  New Zealand,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events Up to 12 months
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