Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
NCT ID: NCT02066545
Last Updated: 2015-09-17
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
327 participants
INTERVENTIONAL
2014-04-30
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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Vehicle Gel
CLS001 Topical Gel Vehicle
CLS001 topical gel 1%
Topical application once daily
CLS001 Topical Gel
CLS001 topical gel 1.75%
Topical application once daily
CLS001 Topical Gel
CLS001 topical gel 2.5%
Topical application once daily
CLS001 Topical Gel
Interventions
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CLS001 Topical Gel
CLS001 Topical Gel Vehicle
Eligibility Criteria
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Inclusion Criteria
* Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
* An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)
Exclusion Criteria
* Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
* Subjects with more than 2 facial nodulocystic lesions
12 Years
ALL
No
Sponsors
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Maruho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Encino Research Center
Encino, California, United States
Skin Surgery Medical Group, Inc.
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Skin Care Research, Inc.
Boca Raton, Florida, United States
Belleair Research Center
Pinellas Park, Florida, United States
Moore Clinical Research, Inc.
Tampa, Florida, United States
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Manhattan Dermatology & Cosmetic Center
New York, New York, United States
Derm Research Center of New York, Inc.
Stony Brook, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Premier Research
Austin, Texas, United States
J & S Studies, Inc.
College Station, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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Other Identifiers
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CLS001-CO-PR-003
Identifier Type: -
Identifier Source: org_study_id
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