Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea
1 other identifier
interventional
307
8 countries
28
Brief Summary
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2015
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2018
CompletedResults Posted
Study results publicly available
July 6, 2022
CompletedJuly 19, 2022
July 1, 2022
1.8 years
October 13, 2015
June 13, 2022
July 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Treatment
EXPERIMENTALOmiganan gel applied once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- Subjects with nodular rosacea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maruho Co., Ltd.lead
Study Sites (28)
Unknown Facility
Fremont, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miramar, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Arlington Heights, Illinois, United States
Unknown Facility
Carmel, Indiana, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Plainfield, Indiana, United States
Unknown Facility
Watertown, Massachusetts, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Pflugerville, Texas, United States
Unknown Facility
Webster, Texas, United States
Unknown Facility
Sydney, New South Wales, Australia
Unknown Facility
Woolloongabba, Queensland, Australia
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Drummondville, Quebec, Canada
Unknown Facility
Cannes, France
Unknown Facility
Nice, France
Unknown Facility
Bergen op Zoom, Netherlands
Unknown Facility
Hamilton, New Zealand
Unknown Facility
Wellington, New Zealand
Unknown Facility
Gothenburg, Sweden
Unknown Facility
Lanarkshire, United Kingdom
Unknown Facility
Manchester, United Kingdom
Related Publications (1)
You Y, Liu H, Zhu Y, Zheng H. Rational design of stapled antimicrobial peptides. Amino Acids. 2023 Apr;55(4):421-442. doi: 10.1007/s00726-023-03245-w. Epub 2023 Feb 12.
PMID: 36781451DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maruho Co.,Ltd. Kyoto R&D Center
- Organization
- Clinical Development Dept.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 15, 2015
Study Start
October 1, 2015
Primary Completion
July 14, 2017
Study Completion
February 8, 2018
Last Updated
July 19, 2022
Results First Posted
July 6, 2022
Record last verified: 2022-07