Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
NCT ID: NCT02785159
Last Updated: 2020-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2016-02-29
2016-12-31
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
QUADRUPLE
Study Groups
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IDP-118 Lotion
Lotion
IDP-118 Lotion
Lotion
Tazorac Cream
Cream
Tazorac Cream
Cream
IDP 118 Vehicle Lotion
Lotion
IDP-118 Vehicle Lotion
Lotion
IDP-118 Vehicle Cream
Cream
IDP-118 Vehicle Cream
Cream
Interventions
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IDP-118 Lotion
Lotion
Tazorac Cream
Cream
IDP-118 Vehicle Lotion
Lotion
IDP-118 Vehicle Cream
Cream
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a Body Surface Area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an (IGA) Investigator Global Assessment score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment, if psoriasis is present.)
Exclusion Criteria
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
18 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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Binu J Alexander, MD
Role: STUDY_DIRECTOR
Valeant Pharmaceuticals
Locations
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Valeant Site 12
Encino, California, United States
Valeant Site 13
Orange Park, Florida, United States
Valeant Site 11
Pinellas Park, Florida, United States
Valeant Site 01
Tampa, Florida, United States
Valeant Site 04
Tampa, Florida, United States
Valeant Site 05
Plainfield, Indiana, United States
Valeant Site 09
Clarkston, Michigan, United States
Valeant Site 07
Fridley, Minnesota, United States
Valeant Site 14
Saint Joseph, Missouri, United States
Valeant Site 10
Greenville, South Carolina, United States
Valeant Site 03
Murfreesboro, Tennessee, United States
Valeant Site 06
College Station, Texas, United States
Valeant Site 08
Webster, Texas, United States
Valeant Site 02
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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V01-118A-202
Identifier Type: -
Identifier Source: org_study_id
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