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Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel

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. Identifier: NCT02576847
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : July 18, 2018
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.

Condition or disease Intervention/treatment Phase
Rosacea Drug: Omiganan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea
Study Start Date : September 2015
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Treatment
Omiganan gel applied once daily
Drug: Omiganan
Topical gel

Primary Outcome Measures :
  1. Safety Adverse Events [ Time Frame: Up to 12 months ]
    Adverse Events

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

Inclusion Criteria:

  1. Healthy, male and nonpregnant female subjects, 18 years of age or older.
  2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
  3. Subjects with the presence of telangiectasia at Baseline
  4. Subjects with the presence of facial erythema associated with their rosacea 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 identifier (NCT number): NCT02576847

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United States, California
Fremont, California, United States
United States, Florida
Miami, Florida, United States
Miramar, Florida, United States
Tampa, Florida, United States
United States, Illinois
Arlington Heights, Illinois, United States
United States, Indiana
Carmel, Indiana, United States
Indianapolis, Indiana, United States
Plainfield, Indiana, United States
United States, Massachusetts
Watertown, Massachusetts, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
New York, New York, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Pflugerville, Texas, United States
Webster, Texas, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Australia, Queensland
Woolloongabba, Queensland, Australia
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Quebec
Drummondville, Quebec, Canada
Cannes, France
Nice, France
Bergen Op Zoom, Netherlands
New Zealand
Hamilton, New Zealand
Wellington, New Zealand
Gothenburg, Sweden
United Kingdom
Lanarkshire, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Maruho Co., Ltd.

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Responsible Party: Maruho Co., Ltd. Identifier: NCT02576847    
Other Study ID Numbers: CLS001-CO-PR-006
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Skin Diseases