Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
NCT ID: NCT03003247
Last Updated: 2017-12-18
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
364 participants
INTERVENTIONAL
2015-11-30
2016-09-30
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
QUADRUPLE
Study Groups
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IDP-120 Gel
IDP-120 Gel is a combination treatment
IDP-120 Gel
IDP-120 Gel is a combination product
IDP-120 Component A Gel
IDP-120 Monad Gel of Component A
IDP 120 Component A Gel
Monad of Component A
IDP-120 Component B Gel
IDP-120 Monad Gel of Component B
IDP 120 Component B Gel
Monad of Component B
IDP-120 Vehicle Gel
IDP-120 Vehicle Gel
IDP 120 Vehicle Gel
Vehicle
Interventions
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IDP-120 Gel
IDP-120 Gel is a combination product
IDP 120 Component A Gel
Monad of Component A
IDP 120 Component B Gel
Monad of Component B
IDP 120 Vehicle Gel
Vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
* Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
* If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.
Exclusion Criteria
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis.
* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
* Subjects with a facial beard or mustache that could interfere with the study assessments.
9 Years
ALL
Yes
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anya Loncaric
Role: STUDY_DIRECTOR
Valeant Pharmaceuticals
Locations
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Valeant Site 15
Encino, California, United States
Valeant Site 13
Lake Mary, Florida, United States
Valeant Site 16
Miami, Florida, United States
Valeant Site 14
Tampa, Florida, United States
Valeant Site 02
West Palm Beach, Florida, United States
Valeant Site 21
Atlanta, Georgia, United States
Valeant Site 23
South Bend, Indiana, United States
Valeant Site 09
Detroit, Michigan, United States
Valeant Site 24
Minneapolis, Minnesota, United States
Valeant Site 11
Saint Joseph, Missouri, United States
Valreant Site 05
New York, New York, United States
Valeant Site 06
New York, New York, United States
Valeant Site 01
Chapel Hill, North Carolina, United States
Valeant Site 17
High Point, North Carolina, United States
Valeant Site 22
Columbus, Ohio, United States
Valeant Site 04
Knoxville, Tennessee, United States
Valeant Site 07
Austin, Texas, United States
Valeant Site 12
Austin, Texas, United States
Valeant Site 18
San Antonio, Texas, United States
Valeant Site 25
Spokane, Washington, United States
Valeant Site 10
Winnepeg, Manitoba, Canada
Valeant Site 03
Markham, Ontario, Canada
Valeant Site 08
Waterloo, Ontario, Canada
Valeant Site 20
Windsor, Ontario, Canada
Countries
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Other Identifiers
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V01-120A-201
Identifier Type: -
Identifier Source: org_study_id