Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
NCT ID: NCT02515097
Last Updated: 2020-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2015-11-05
2017-03-15
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-122 Lotion
Participants will apply IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks.
IDP-122 Lotion
Medicated topical lotion
IDP-122 Vehicle Lotion
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
IDP-122 Vehicle Lotion
Vehicle topical lotion with no active ingredient
Interventions
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IDP-122 Lotion
Medicated topical lotion
IDP-122 Vehicle Lotion
Vehicle topical lotion with no active ingredient
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 score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).
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
No
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
Role: STUDY_DIRECTOR
Valeant Pharmaceuticals
Locations
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Valeant Site 14
Santa Ana, California, United States
Valeant Site 02
Boynton Beach, Florida, United States
Valeant Site 10
Clearwater, Florida, United States
Valeant Site 1
Tampa, Florida, United States
Valeant Site 07
Plainfield, Indiana, United States
Valeant Site 15
Olathe, Kansas, United States
Valeant Site 08
Fridley, Minnesota, United States
Valeant Site 13
Omaha, Nebraska, United States
Valeant Site 04
New York, New York, United States
Valeant Site 12
Stony Brook, New York, United States
Valeant Site 05
High Point, North Carolina, United States
Valeant Site 11
Knoxville, Tennessee, United States
Valeant Site 03
Houston, Texas, United States
Valeant Site 09
San Antonio, Texas, United States
Valeant Site 06
West Jordan, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V01-122A-302
Identifier Type: -
Identifier Source: org_study_id
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