Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
1 other identifier
interventional
154
1 country
14
Brief Summary
Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2016
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
August 20, 2020
CompletedAugust 20, 2020
August 1, 2020
8 months
April 26, 2016
August 8, 2020
August 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Subjects With Treatment Success
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
2 weeks
Study Arms (4)
IDP-118 Lotion
EXPERIMENTALLotion
Ultravate Cream
ACTIVE COMPARATORCream
IDP-118 Vehicle Lotion
ACTIVE COMPARATORLotion
IDP-118 Vehicle Cream
ACTIVE COMPARATORCream
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, of any race, at least 18 years of age (inclusive).
- 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.
You may not qualify if:
- Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Valeant Site 12
Fullerton, California, 92831, United States
Valeant Site 04
La Mesa, California, 91941, United States
Valeant Site 03
San Diego, California, 92093, United States
Valeant Site 09
San Diego, California, 92093, United States
Valeant Site 05
Lauderdale Lakes, Florida, 33313, United States
Valeant Site 02
Miami, Florida, 33111, United States
Valeant Site 07
Fridley, Minnesota, 55421, United States
Valeant Site 08
Chapel Hill, North Carolina, 27514, United States
Valeant Site 06
Columbus, Ohio, 43085, United States
Valeant Site 13
Mt. Pleasant, South Carolina, 29464, United States
Valeant Site 11
Katy, Texas, 77449, United States
Valeant Site 10
San Antonio, Texas, 78201, United States
Valeant Site 01
Sugar Land, Texas, 77479, United States
Valeant Site 14
Salt Lake City, Utah, 84103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Binu J Alexander, MD
Valeant Pharmaceuticals
- STUDY DIRECTOR
Binu Alexander
Valeant Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
May 27, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
August 20, 2020
Results First Posted
August 20, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share