Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% Halobetasol Propionate) to Ultravate® (Halobetasol Propionate) Cream, in the Treatment of Plaque Psoriasis
1 other identifier
interventional
150
1 country
13
Brief Summary
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2016
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
August 27, 2020
CompletedAugust 27, 2020
August 1, 2020
6 months
April 26, 2016
August 8, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2
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" at Week 2. 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-122 Lotion
EXPERIMENTALLotion
Ultravate Cream
ACTIVE COMPARATORCream
IDP-122 Vehicle Lotion
ACTIVE COMPARATORLotion
IDP-122 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.
- Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
- 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 (13)
Valeant Site 05
Rogers, Arkansas, 75758, United States
Valeant Site 10
Beverly Hills, California, 90210, United States
Valeant Site 09
Carlsbad, California, 92008, United States
Valeant Site 13
Los Angeles, California, 90045, United States
Valeant Site 12
Santa Monica, California, 90404, United States
Valeant Site 07
Coral Gables, Florida, 33134, United States
Valeant Site 11
North Miami Beach, Florida, 33162, United States
Valeant Site 03
Sanford, Florida, 32771, United States
Valeant Site 08
Albany, Indiana, 47150, United States
Valeant Site 04
Louisville, Kentucky, 40202, United States
Valeant Site 06
Fridley, Minnesota, 55432, United States
Valeant Site 02
High Point, North Carolina, 27262, United States
Valeant Site 01
Houston, Texas, 77065, United States
Related Publications (1)
Kerdel FA, Draelos ZD, Tyring SK, Lin T, Pillai R. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis. J Dermatolog Treat. 2019 Jun;30(4):333-339. doi: 10.1080/09546634.2018.1523362. Epub 2018 Nov 5.
PMID: 30207807DERIVED
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
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
June 1, 2016
Primary Completion
December 2, 2016
Study Completion
January 1, 2017
Last Updated
August 27, 2020
Results First Posted
August 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share