Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
NCT ID: NCT02576860
Last Updated: 2022-08-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
263 participants
INTERVENTIONAL
2015-10-31
2017-09-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
NCT02547441
A Twelve Week Safety and Efficacy Study in Rosacea
NCT01784133
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
NCT02576847
A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
NCT02571998
Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
NCT02066545
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan)
Topical gel
Vehicle Gel
Vehicle gel applied once daily
Vehicle
Vehicle gel
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CLS001 (Omiganan)
Topical gel
Vehicle
Vehicle gel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Maruho Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fort Smith, Arkansas, United States
Rogers, Arkansas, United States
Manhattan Beach, California, United States
Oceanside, California, United States
Washington D.C., District of Columbia, United States
Boynton Beach, Florida, United States
Miami, Florida, United States
Plainfield, Indiana, United States
Watertown, Massachusetts, United States
Omaha, Nebraska, United States
Verona, New Jersey, United States
New York, New York, United States
Stony Brook, New York, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fort Washington, Pennsylvania, United States
Charleston, South Carolina, United States
Arlington, Texas, United States
San Antonio, Texas, United States
Phillip, Australian Capital Territory, Australia
Kogarah, New South Wales, Australia
Liverpool, New South Wales, Australia
Box Hill, Victoria, Australia
Surrey, British Columbia, Canada
Courtice, Ontario, Canada
Peterborough, Ontario, Canada
Windsor, Ontario, Canada
Grenoble, , France
Nantes, , France
Quimper, , France
Berlin, , Germany
Bochum, , Germany
Bonn, , Germany
Cologne, , Germany
Friedrichshafen, , Germany
Hamburg, , Germany
Lingen, , Germany
Mönchengladbach, , Germany
Osnabrück, , Germany
Schweinfurt, , Germany
Nijmegen, , Netherlands
Auckland, , New Zealand
Halmstad, , Sweden
Bradford, England, United Kingdom
Birmingham, , United Kingdom
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLS001-CO-PR-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.