Back to resultsStudy to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CLS001 (Omiganan)
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- Subjects with nodular rosacea.
- Standard exclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Vehicle Gel
Arm Description
CLS001 (Omiganan) gel applied once daily
Vehicle gel applied once daily
Outcomes
Primary Outcome Measures
Change in Inflammatory Lesion Count From Baseline to Week 12
Change from Baseline to Week 12 in Inflammatory Lesion Count
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).
Secondary Outcome Measures
Change in the Number of Inflammatory Lesions From Baseline at Week 9
The absolute change in inflammatory lesions from baseline to Week 9
Change in the Number of Inflammatory Lesions From Baseline at Week 6
The absolute change in inflammatory lesions from baseline to Week 6
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
Percentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
Percentage of participants who achieved 2 grade IGA reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547441
Brief Title
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
July 5, 2017 (Actual)
Study Completion Date
April 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
463 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
CLS001 (Omiganan) gel applied once daily
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle gel applied once daily
Intervention Type
Drug
Intervention Name(s)
CLS001 (Omiganan)
Intervention Description
Topical gel
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle Gel
Primary Outcome Measure Information:
Title
Change in Inflammatory Lesion Count From Baseline to Week 12
Description
Change from Baseline to Week 12 in Inflammatory Lesion Count
Time Frame
12 weeks
Title
Percentage of Participants Who Achieved 2 Grade IGA Reduction.
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in the Number of Inflammatory Lesions From Baseline at Week 9
Description
The absolute change in inflammatory lesions from baseline to Week 9
Time Frame
9 weeks
Title
Change in the Number of Inflammatory Lesions From Baseline at Week 6
Description
The absolute change in inflammatory lesions from baseline to Week 6
Time Frame
6 weeks
Title
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
Description
Percentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame
9 Weeks
Title
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
Description
Percentage of participants who achieved 2 grade IGA reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
Subjects with nodular rosacea.
Standard exclusion criteria.
Facility Information:
City
Fremont
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Miramar
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Arlington Heights
State/Province
Illinois
Country
United States
City
Carmel
State/Province
Indiana
Country
United States
City
Fort Gratiot
State/Province
Michigan
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Woolloongabba
State/Province
Queensland
Country
Australia
City
Carlton
State/Province
Victoria
Country
Australia
City
East Melbourne
State/Province
Victoria
Country
Australia
City
Hamilton
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Brest
Country
France
City
Nancy
Country
France
City
Nice
Country
France
City
Rouen
Country
France
City
Thionville
Country
France
City
Augsburg
Country
Germany
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Darmstadt
Country
Germany
City
Dresden
Country
Germany
City
Dulmen
Country
Germany
City
Frankfurt
Country
Germany
City
Ibbenbueren
Country
Germany
City
Lubeck
Country
Germany
City
Mahlow
Country
Germany
City
Munster
Country
Germany
City
Rotterdam
Country
Netherlands
City
Hamilton
Country
New Zealand
City
Gothenburg
Country
Sweden
City
Lanarkshire
Country
United Kingdom
City
Leeds
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Surrey
Country
United Kingdom
12. IPD Sharing Statement
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Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
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