Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
NCT ID: NCT03058744
Last Updated: 2017-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
94 participants
INTERVENTIONAL
2015-04-30
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-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
NCT02785172
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
NCT02785159
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 in the Treatment of Plaque Psoriasis
NCT02045277
A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis
NCT03988439
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IDP-118 Lotion
8 Weeks
IDP-118 Lotion
Lotion
HP Monad Lotion
8 Weeks
HP Monad Lotion
Lotion
Ultravate Cream
2 Weeks
Ultravate Cream
Cream
Tazorac Cream
4 Weeks
Tazorac Cream
Cream
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IDP-118 Lotion
Lotion
HP Monad Lotion
Lotion
Ultravate Cream
Cream
Tazorac 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 written and oral informed consent.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
* Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
* The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Exclusion Criteria
* Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
* Has a history of adrenal disease.
* Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing, or planning pregnancy during the study period.
18 Years
ALL
No
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.
Lindsey Mathew
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
Anaheim, California, United States
Valeant Site 05
Encino, California, United States
Valeant Site 01
San Diego, California, United States
Valeant Site 07
Santa Rosa, California, United States
Valeant Site 10
Orange Park, Florida, United States
Valeant Site 09
Sanford, Florida, United States
Valeant Site 08
Atlanta, Georgia, United States
Valeant Site 04
Plainfield, Indiana, United States
Valeant Site 06
New York, New York, United States
Valeant Site 11
Philadelphia, Pennsylvania, United States
Valeant Site 03
Austin, Texas, United States
Valeant Site 02
Katy, Texas, 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-501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.