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
Overview
- Phase
- Phase 2
- Intervention
- IDP-122 Vehicle Lotion
- Conditions
- Psoriasis
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 150
- Locations
- 13
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.
Detailed Description
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, 0.05% in the Treatment of Plaque Psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
IDP-122 Vehicle Lotion
Lotion
Intervention: IDP-122 Vehicle Lotion
IDP-122 Lotion
Lotion
Intervention: IDP-122 Lotion
Ultravate Cream
Cream
Intervention: Ultravate Cream
IDP-122 Vehicle Cream
Cream
Intervention: IDP-122 Vehicle Cream
Outcomes
Primary Outcomes
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
Time Frame: 2 weeks
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).