A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
NCT ID: NCT02571998
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
320 participants
INTERVENTIONAL
2015-10-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
Omiganan (CLS001) Topical Gel applied once daily
Omiganan (CLS001) Topical Gel
Vehicle Gel
Vehicle Topical Gel applied once daily
Vehicle Topical Gel
Interventions
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Omiganan (CLS001) Topical Gel
Vehicle Topical Gel
Eligibility Criteria
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Inclusion Criteria
* Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
* Subjects with ≥ 30 facial inflammatory lesions
Exclusion Criteria
* Subjects with \> 3 facial nodular or cystic lesions at Baseline
12 Years
FEMALE
No
Sponsors
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Maruho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Santa Ana, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Miami, Florida, United States
Pinellas Park, Florida, United States
Sanford, Florida, United States
Tampa, Florida, United States
Beverly, Massachusetts, United States
Fort Gratiot, Michigan, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Newington, New Hampshire, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Stony Brook, New York, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Knoxville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Pflugerville, Texas, United States
San Antonio, Texas, United States
Webster, Texas, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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CLS001-CO-PR-009
Identifier Type: -
Identifier Source: org_study_id
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