Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT02785172
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis
- Detailed Description
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- 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.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDP-118 Vehicle Cream IDP-118 Vehicle Cream Cream IDP-118 Lotion IDP-118 Lotion Lotion Ultravate Cream Ultravate Cream Cream IDP-118 Vehicle Lotion IDP-118 Vehicle Lotion Lotion
- Primary Outcome Measures
Name Time Method Percent of Subjects With Treatment Success 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". 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Valeant Site 03
🇺🇸San Diego, California, United States
Valeant Site 07
🇺🇸Fridley, Minnesota, United States
Valeant Site 06
🇺🇸Columbus, Ohio, United States
Valeant Site 05
🇺🇸Lauderdale Lakes, Florida, United States
Valeant Site 09
🇺🇸San Diego, California, United States
Valeant Site 14
🇺🇸Salt Lake City, Utah, United States
Valeant Site 12
🇺🇸Fullerton, California, United States
Valeant Site 04
🇺🇸La Mesa, California, United States
Valeant Site 11
🇺🇸Katy, Texas, United States
Valeant Site 08
🇺🇸Chapel Hill, North Carolina, United States
Valeant Site 02
🇺🇸Miami, Florida, United States
Valeant Site 01
🇺🇸Sugar Land, Texas, United States
Valeant Site 10
🇺🇸San Antonio, Texas, United States
Valeant Site 13
🇺🇸Mount Pleasant, South Carolina, United States