Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
NCT ID: NCT01701024
Last Updated: 2018-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
498 participants
INTERVENTIONAL
2012-10-31
2013-07-31
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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ACYC
ACYC active, topically applied to the face for 12 weeks
ACYC
ACYC active, topically applied to the face for 12 weeks
ACYC vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks
ACYC vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Interventions
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ACYC
ACYC active, topically applied to the face for 12 weeks
ACYC vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Written and verbal informed consent must be obtained.
* Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent
* Subject must have moderate to severe acne at the baseline visit
* Women of childbearing potential must be willing to practice effective contraception for the duration of the study
Exclusion Criteria
* Dermatological conditions on the face that could interfere with clinical evaluations
12 Years
40 Years
ALL
No
Sponsors
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Dow Pharmaceutical Sciences
INDUSTRY
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nilima Justice, M.D.
Role: STUDY_DIRECTOR
Medical Monitor, Valeant Pharmaceuticals
Locations
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Mobile, Alabama, United States
Los Angeles, California, United States
San Diego, California, United States
New Haven, Connecticut, United States
Aventura, Florida, United States
Naperville, Illinois, United States
Evansville, Indiana, United States
South Bend, Indiana, United States
Louisville, Kentucky, United States
Clinton Township, Michigan, United States
Fridley, Minnesota, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Portland, Oregon, United States
Goodlettsville, Tennessee, United States
Austin, Texas, United States
College Station, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Lynchburg, Virginia, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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V01-ACYC-301
Identifier Type: -
Identifier Source: org_study_id
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