Back to resultsStudy to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Omiganan
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria:
- Healthy, male and nonpregnant female subjects, 18 years of age or older.
- A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
- Subjects with the presence of telangiectasia at Baseline
- Subjects with the presence of facial erythema associated with their rosacea at Baseline
Exclusion Criteria:
- Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- Subjects with nodular rosacea
- Standard exclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Omiganan gel applied once daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02576847
Brief Title
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Official Title
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
February 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Omiganan gel applied once daily
Intervention Type
Drug
Intervention Name(s)
Omiganan
Intervention Description
Topical gel
Primary Outcome Measure Information:
Title
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
Description
Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, male and nonpregnant female subjects, 18 years of age or older.
A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
Subjects with the presence of telangiectasia at Baseline
Subjects with the presence of facial erythema associated with their rosacea at Baseline
Exclusion Criteria:
Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
Subjects with nodular rosacea
Standard exclusion criteria.
Facility Information:
City
Fremont
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Miramar
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Arlington Heights
State/Province
Illinois
Country
United States
City
Carmel
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Plainfield
State/Province
Indiana
Country
United States
City
Watertown
State/Province
Massachusetts
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Pflugerville
State/Province
Texas
Country
United States
City
Webster
State/Province
Texas
Country
United States
City
Sydney
State/Province
New South Wales
Country
Australia
City
Woolloongabba
State/Province
Queensland
Country
Australia
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Drummondville
State/Province
Quebec
Country
Canada
City
Cannes
Country
France
City
Nice
Country
France
City
Bergen Op Zoom
Country
Netherlands
City
Hamilton
Country
New Zealand
City
Wellington
Country
New Zealand
City
Gothenburg
Country
Sweden
City
Lanarkshire
Country
United Kingdom
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
We'll reach out to this number within 24 hrs