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A Twelve Week Safety and Efficacy Study in Rosacea

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: NCT01784133
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: omiganan Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
Study Start Date : March 2013
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Active Comparator: omiganan mid dose
omiganan mid dose once daily application for 12 weeks
Drug: omiganan
Active Comparator: omiganan high dose
omiganan high dose once daily application for 12 weeks
Drug: omiganan
Placebo Comparator: Vehicle group
Vehicle once daily application for 12 weeks
Drug: placebo
Active Comparator: omiganan low dose
omiganan low dose once daily application for 12 weeks
Drug: omiganan



Primary Outcome Measures :
  1. Change in inflammatory lesion count [ Time Frame: 0, 1, 3, 6, 9 and 12 weeks ]

Secondary Outcome Measures :
  1. Success on IGA defined as clear or almost clear [ Time Frame: Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion Criteria:

  • nodular rosacea or subtype 3
  • clinically significant abnormal findings that would interfere with study objectives

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): NCT01784133


Locations
Show Show 17 study locations
Sponsors and Collaborators
Maruho Co., Ltd.

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT01784133    
Other Study ID Numbers: CLS001-CO-PR-001
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Maruho Co., Ltd.:
rosacea
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Antimicrobial Cationic Peptides
Anti-Infective Agents