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 a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension
1 other identifier
interventional
463
9 countries
41
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 Dec 2015
41 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
First Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2018
CompletedResults Posted
Study results publicly available
August 2, 2022
CompletedAugust 2, 2022
July 1, 2022
1.6 years
September 9, 2015
June 13, 2022
July 31, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Inflammatory Lesion Count From Baseline to Week 12
Change from Baseline to Week 12 in Inflammatory Lesion Count
12 weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction.
Percentage of participants 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)
Change in the Number of Inflammatory Lesions From Baseline at Week 9
9 weeks
Change in the Number of Inflammatory Lesions From Baseline at Week 6
6 weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
9 Weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
6 Weeks
Study Arms (2)
Treatment
EXPERIMENTALCLS001 (Omiganan) 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 (41)
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
Fort Gratiot, Michigan, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Stony Brook, New York, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Woolloongabba, Queensland, Australia
Unknown Facility
Carlton, Victoria, Australia
Unknown Facility
East Melbourne, Victoria, Australia
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Brest, France
Unknown Facility
Nancy, France
Unknown Facility
Nice, France
Unknown Facility
Rouen, France
Unknown Facility
Thionville, France
Unknown Facility
Augsburg, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Bochum, Germany
Unknown Facility
Darmstadt, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Dülmen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Ibbenbueren, Germany
Unknown Facility
Lübeck, Germany
Unknown Facility
Mahlow, Germany
Unknown Facility
Münster, Germany
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Hamilton, New Zealand
Unknown Facility
Gothenburg, Sweden
Unknown Facility
Lanarkshire, United Kingdom
Unknown Facility
Leeds, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Surrey, 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
September 9, 2015
First Posted
September 11, 2015
Study Start
December 1, 2015
Primary Completion
July 5, 2017
Study Completion
April 13, 2018
Last Updated
August 2, 2022
Results First Posted
August 2, 2022
Record last verified: 2022-07