Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
NCT ID: NCT02785172
Last Updated: 2020-08-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2016-04-30
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis
NCT02785185
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
NCT02785159
Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
NCT03058744
Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
NCT02045277
Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
NCT02462070
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IDP-118 Lotion
Lotion
IDP-118 Lotion
Lotion
Ultravate Cream
Cream
Ultravate Cream
Cream
IDP-118 Vehicle Lotion
Lotion
IDP-118 Vehicle Lotion
Vehicle
IDP-118 Vehicle Cream
Cream
IDP-118 Vehicle Cream
Vehicle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IDP-118 Vehicle Lotion
Vehicle
IDP-118 Vehicle Cream
Vehicle
IDP-118 Lotion
Lotion
Ultravate Cream
Cream
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA (Body Surface Area) 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 (Investigators 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.)
* If female and of childbearing potential, must have a negative urine and serum pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit prior to randomization.
* Subject is willing to comply with study instructions and return to the clinic for required visits.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Binu J Alexander, MD
Role: STUDY_DIRECTOR
Valeant Pharmaceuticals
Binu Alexander
Role: STUDY_DIRECTOR
Valeant Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Valeant Site 12
Fullerton, California, United States
Valeant Site 04
La Mesa, California, United States
Valeant Site 03
San Diego, California, United States
Valeant Site 09
San Diego, California, United States
Valeant Site 05
Lauderdale Lakes, Florida, United States
Valeant Site 02
Miami, Florida, United States
Valeant Site 07
Fridley, Minnesota, United States
Valeant Site 08
Chapel Hill, North Carolina, United States
Valeant Site 06
Columbus, Ohio, United States
Valeant Site 13
Mt. Pleasant, South Carolina, United States
Valeant Site 11
Katy, Texas, United States
Valeant Site 10
San Antonio, Texas, United States
Valeant Site 01
Sugar Land, Texas, United States
Valeant Site 14
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V01-118A-203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.