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Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576860
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: CLS001 (Omiganan) Drug: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2015
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : September 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Treatment
CLS001 (Omignan) gel applied once daily
Drug: CLS001 (Omiganan)
Topical gel

Placebo Comparator: Vehicle Gel
Vehicle gel applied once daily
Drug: Vehicle
Vehicle gel




Primary Outcome Measures :
  1. Efficacy Absolute change in inflammatory lesion count [ Time Frame: 12 weeks ]
    Absolute change in inflammatory lesion count

  2. Efficacy IGA: 2 grade reduction [ Time Frame: 12 weeks ]
    IGA: 2 grade reduction; Clear or almost clear

  3. Safety Adverse events [ Time Frame: 12 weeks ]
    Adverse events


Secondary Outcome Measures :
  1. Efficacy The absolute change in inflammatory lesions [ Time Frame: 9 weeks ]
    The absolute change in inflammatory lesions

  2. Efficacy The absolute change in inflammatory lesions [ Time Frame: 6 weeks ]
    The absolute change in inflammatory lesions

  3. Efficacy IGA: 2 point reduction [ Time Frame: 9 Weeks ]
    IGA: 2 point reduction; Clear or almost clear

  4. Efficacy IGA: 2 point reduction [ Time Frame: 6 Weeks ]
    IGA: 2 point reduction; Clear or almost clear



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy, male and non-pregnant female subjects, 18 years of age or older.
  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:

  1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
  2. Subjects with nodular rosacea.
  3. Standard exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576860


Locations
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United States, Arkansas
Fort Smith, Arkansas, United States
Rogers, Arkansas, United States
United States, California
Manhattan Beach, California, United States
Oceanside, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Boynton Beach, Florida, United States
Miami, Florida, United States
United States, Indiana
Plainfield, Indiana, United States
United States, Massachusetts
Watertown, Massachusetts, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Jersey
Verona, New Jersey, United States
United States, New York
New York, New York, United States
Stony Brook, New York, United States
United States, North Carolina
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Fort Washington, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Arlington, Texas, United States
San Antonio, Texas, United States
Australia, Australian Capital Territory
Phillip, Australian Capital Territory, Australia
Australia, New South Wales
Kogarah, New South Wales, Australia
Liverpool, New South Wales, Australia
Australia
Victoria, Australia
Canada, British Columbia
Surrey, British Columbia, Canada
Canada, Ontario
Courtice, Ontario, Canada
Peterborough, Ontario, Canada
Windsor, Ontario, Canada
France
Grenoble, France
Nantes, France
Quimper, France
Germany
Berlin, Germany
Bochum, Germany
Bonn, Germany
Friedrichshafen, Germany
Hamburg, Germany
Koeln, Germany
Lingen, Germany
Monchengladbach, Germany
Osnabruck, Germany
Schweinfurt, Germany
Netherlands
Nijmegen, Netherlands
New Zealand
Auckland, New Zealand
Sweden
Halmstad, Sweden
United Kingdom
Bradford, England, United Kingdom
Birmingham, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Maruho Co., Ltd.
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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT02576860    
Other Study ID Numbers: CLS001-CO-PR-005
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Rosacea
Skin Diseases