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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: NCT02547441
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : July 10, 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 : 463 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 a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension
Study Start Date : October 2015
Actual Primary Completion Date : July 5, 2017
Actual Study Completion Date : April 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Treatment
CLS001 (Omiganan) 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



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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): NCT02547441


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Sponsors and Collaborators
Maruho Co., Ltd.

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT02547441     History of Changes
Other Study ID Numbers: CLS001-CO-PR-004
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Rosacea
Skin Diseases