Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
NCT ID: NCT02462083
Last Updated: 2020-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
555 participants
INTERVENTIONAL
2015-08-11
2017-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IDP-118 Lotion
IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
IDP-118 Lotion
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
Interventions
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IDP-118 Lotion
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
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 percent (%), 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 Investigators Global Assessment (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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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 6
Mobile, Alabama, United States
Valeant Site 24
Beverly Hills, California, United States
Valeant Site 32
Encinitas, California, United States
Valeant Site 27
Encino, California, United States
Valeant Site 33
Los Angeles, California, United States
Valeant Site 43
Los Angeles, California, United States
Valeant Site 45
Sacramento, California, United States
Valeant Site 25
San Diego, California, United States
Valeant Site 4
San Diego, California, United States
Valeant Site 44
Santa Monica, California, United States
Valeant Site 36
Santa Rosa, California, United States
Valeant Site 10
Englewood, Colorado, United States
Valeant Site 3
Boynton Beach, Florida, United States
Valeant Site 28
Coral Gables, Florida, United States
Valeant Site 1
Miami, Florida, United States
Valeant Site 37
North Miami Beach, Florida, United States
Valeant Site 13
Sanford, Florida, United States
Valeant Site 41
Snellville, Georgia, United States
Valeant Site 17
South Bend, Indiana, United States
Valeant Site 12
Olathe, Kansas, United States
Valeant Site 19
Louisville, Kentucky, United States
Valeant Site 14
Louisville, Kentucky, United States
Valeant Site 35
Clinton Township, Michigan, United States
Valeant Site 34
Detroit, Michigan, United States
Valeant Site 16
Warren, Michigan, United States
Valeant Site 18
Fridley, Minnesota, United States
Valeant Site 31
Omaha, Nebraska, United States
Valeant Site 2
East Windsor, New Jersey, United States
Valeant Site 29
New York, New York, United States
Valeant Site 39
Rochester, New York, United States
Valeant Site 5
Portland, Oregon, United States
Valeant Site 11
Philadelphia, Pennsylvania, United States
Valeant Site 30
Charleston, South Carolina, United States
Valeant Site 15
Nashville, Tennessee, United States
Valeant Site 9
Dallas, Texas, United States
Valeant Site 40
Houston, Texas, United States
Valeant Site 8
Houston, Texas, United States
Valeant Site 46
Katy, Texas, United States
Valeant Site 20
Pflugerville, Texas, United States
Valeant Site 21
San Antonio, Texas, United States
Valeant Site 7
San Antonio, Texas, United States
Valeant Site 22
Webster, Texas, United States
Valeant Site 38
Salt Lake City, Utah, United States
Valeant Site 23
Lynchburg, Virginia, United States
Valeant Site 26
Norfolk, Virginia, United States
Valeant Site 42
Spokane, Washington, 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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V01-118A-303
Identifier Type: -
Identifier Source: org_study_id
NCT02611349
Identifier Type: -
Identifier Source: nct_alias
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