Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
NCT ID: NCT02045277
Last Updated: 2020-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
212 participants
INTERVENTIONAL
2014-02-28
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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IDP-118 Lotion
halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion
Lotion
IDP-118 Monad HP Lotion
HP
IDP-118 Monad HP Lotion
Active Comparator
IDP-118 Monad Taz Lotion
Taz
IDP-118 Monad Taz Lotion
Active Comparator
IDP-118 Vehicle Lotion
Vehicle
IDP-118 Vehicle Lotion
Vehicle
Interventions
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IDP-118 Lotion
Lotion
IDP-118 Monad HP Lotion
Active Comparator
IDP-118 Monad Taz Lotion
Active Comparator
IDP-118 Vehicle Lotion
Vehicle
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 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, 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
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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Binu J Alexander
Role: STUDY_DIRECTOR
Valeant Pharmaceuticals
Locations
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Valeant Site 13
Encino, California, United States
Valeant Site 11
San Diego, California, United States
Valeant Site 15
Santa Rosa, California, United States
Valeant Site 10
Augusta, Georgia, United States
Valeant Site 09
Newnan, Georgia, United States
Valeant Site 08
Louisville, Kentucky, United States
Valeant Site 04
Rockville, Maryland, United States
Valeant Site 14
Clinton Township, Michigan, United States
Valeant Site 07
Fridley, Minnesota, United States
Valeant Site 01
East Windsor, New Jersey, United States
Valeant Site 03
New York, New York, United States
Valeant Site 17
Rochester, New York, United States
Valeant Site 02
High Point, North Carolina, United States
Valeant Site 05
Austin, Texas, United States
Valeant Site 06
College Station, Texas, United States
Valeant Site 16
Salt Lake City, Utah, United States
Valeant Site 18
Lynchburg, Virginia, United States
Valeant Site 12
Norfolk, Virginia, United States
Countries
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Other Identifiers
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V01-118A-201
Identifier Type: -
Identifier Source: org_study_id
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