Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
NCT ID: NCT02576847
Last Updated: 2022-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
307 participants
INTERVENTIONAL
2015-10-31
2018-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Omiganan gel applied once daily
Omiganan
Topical gel
Interventions
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Omiganan
Topical gel
Eligibility Criteria
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Inclusion Criteria
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
2. Subjects with nodular rosacea
18 Years
ALL
Yes
Sponsors
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Maruho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fremont, California, United States
Miami, Florida, United States
Miramar, Florida, United States
Tampa, Florida, United States
Arlington Heights, Illinois, United States
Carmel, Indiana, United States
Indianapolis, Indiana, United States
Plainfield, Indiana, United States
Watertown, Massachusetts, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Pflugerville, Texas, United States
Webster, Texas, United States
Sydney, New South Wales, Australia
Woolloongabba, Queensland, Australia
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Drummondville, Quebec, Canada
Cannes, , France
Nice, , France
Bergen op Zoom, , Netherlands
Hamilton, , New Zealand
Wellington, , New Zealand
Gothenburg, , Sweden
Lanarkshire, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLS001-CO-PR-006
Identifier Type: -
Identifier Source: org_study_id
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