Psoriasis
Conditions
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.
Interventions
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key 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. Key
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-122 Lotion Lotion
IDP-122 Lotion: Lotion | 60 |
| Ultravate Cream Cream
Ultravate Cream: Cream | 57 |
| IDP-122 Vehicle Lotion Lotion
IDP-122 Vehicle Lotion: Vehicle | 17 |
| IDP-122 Vehicle Cream Cream
IDP-122 Vehicle Cream: Vehicle | 16 |
| Total | 150 |
Baseline characteristics
| Characteristic | IDP-122 Lotion | Ultravate Cream | IDP-122 Vehicle Lotion | IDP-122 Vehicle Cream | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 14.2 | 50.2 years STANDARD_DEVIATION 10.91 | 44.7 years STANDARD_DEVIATION 8.8 | 48.6 years STANDARD_DEVIATION 14.98 | 49.6 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 25 Participants | 27 Participants | 6 Participants | 12 Participants | 70 Participants |
| Sex: Female, Male Male | 35 Participants | 30 Participants | 11 Participants | 4 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 57 | 1 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 60 | 0 / 57 | 0 / 15 | 0 / 16 |
Outcome results
Primary
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).
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IDP-122 Lotion | 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 | 18 Participants |
| Ultravate Cream | 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 | 18 Participants |
| IDP-122 Vehicle Lotion | 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 | 3 Participants |
| IDP-122 Vehicle Cream | 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 | 1 Participants |