Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
NCT ID: NCT02547441
Last Updated: 2022-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
463 participants
INTERVENTIONAL
2015-12-31
2018-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan)
Topical gel
Vehicle Gel
Vehicle gel applied once daily
Vehicle
Vehicle Gel
Interventions
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CLS001 (Omiganan)
Topical gel
Vehicle
Vehicle Gel
Eligibility Criteria
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Inclusion Criteria
2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
3. Subjects with the presence of telangiectasia at Baseline.
4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
5. Subjects with severe rosacea on the Investigators Global Assessment scale 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
Fort Gratiot, Michigan, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Stony Brook, New York, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Woolloongabba, Queensland, Australia
Carlton, Victoria, Australia
East Melbourne, Victoria, Australia
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Brest, , France
Nancy, , France
Nice, , France
Rouen, , France
Thionville, , France
Augsburg, , Germany
Berlin, , Germany
Bochum, , Germany
Darmstadt, , Germany
Dresden, , Germany
Dülmen, , Germany
Frankfurt, , Germany
Ibbenbueren, , Germany
Lübeck, , Germany
Mahlow, , Germany
Münster, , Germany
Rotterdam, , Netherlands
Hamilton, , New Zealand
Gothenburg, , Sweden
Lanarkshire, , United Kingdom
Leeds, , United Kingdom
Manchester, , United Kingdom
Surrey, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLS001-CO-PR-004
Identifier Type: -
Identifier Source: org_study_id
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