Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period
1 other identifier
interventional
263
9 countries
47
Brief Summary
This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle 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
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2017
CompletedResults Posted
Study results publicly available
July 8, 2022
CompletedAugust 2, 2022
July 1, 2022
1.4 years
October 13, 2015
October 8, 2020
July 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy Absolute Change in Inflammatory Lesion Count
Absolute change in inflammatory lesion count from baseline to Week 12.
12 weeks
Efficacy IGA: 2 Grade Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
12 weeks
Secondary Outcomes (4)
Efficacy The Absolute Change in Inflammatory Lesions
9 weeks
Efficacy The Absolute Change in Inflammatory Lesions
6 weeks
Efficacy IGA: 2 Point Reduction
9 Weeks
Efficacy IGA: 2 Point Reduction
6 Weeks
Other Outcomes (1)
Safety Adverse Events
12 weeks
Study Arms (2)
Treatment
EXPERIMENTALCLS001 (Omignan) gel applied once daily
Vehicle Gel
PLACEBO COMPARATORVehicle gel applied once daily
Interventions
Eligibility Criteria
You may qualify if:
- Healthy, male and non-pregnant female subjects, 18 years of age or older.
- A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
- Subjects with the presence of telangiectasia at Baseline.
- Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
- Subjects with severe rosacea on the Investigators Global Assessment scale 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 (47)
Unknown Facility
Fort Smith, Arkansas, United States
Unknown Facility
Rogers, Arkansas, United States
Unknown Facility
Manhattan Beach, California, United States
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Oceanside, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Miami, Florida, United States
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Plainfield, Indiana, United States
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Watertown, Massachusetts, United States
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Omaha, Nebraska, United States
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Verona, New Jersey, United States
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New York, New York, United States
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Stony Brook, New York, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fort Washington, Pennsylvania, United States
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Charleston, South Carolina, United States
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Arlington, Texas, United States
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San Antonio, Texas, United States
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Phillip, Australian Capital Territory, Australia
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Kogarah, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Box Hill, Victoria, Australia
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Surrey, British Columbia, Canada
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Courtice, Ontario, Canada
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Peterborough, Ontario, Canada
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Windsor, Ontario, Canada
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Grenoble, France
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Nantes, France
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Quimper, France
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
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Cologne, Germany
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Friedrichshafen, Germany
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Hamburg, Germany
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Lingen, Germany
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Mönchengladbach, Germany
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Osnabrück, Germany
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Schweinfurt, Germany
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Nijmegen, Netherlands
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Auckland, New Zealand
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Halmstad, Sweden
Unknown Facility
Bradford, England, United Kingdom
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
London, United Kingdom
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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
February 27, 2017
Study Completion
September 5, 2017
Last Updated
August 2, 2022
Results First Posted
July 8, 2022
Record last verified: 2022-07