Psoriasis
Conditions
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
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. * 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
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 |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-118 Lotion Lotion
IDP-118 Lotion: Lotion | 61 |
| Ultravate Cream Cream
Ultravate Cream: Cream | 63 |
| IDP-118 Vehicle Lotion Lotion
IDP-118 Vehicle Lotion: Vehicle | 16 |
| IDP-118 Vehicle Cream Cream
IDP-118 Vehicle Cream: Vehicle | 14 |
| Total | 154 |
Baseline characteristics
| Characteristic | IDP-118 Lotion | Ultravate Cream | IDP-118 Vehicle Lotion | IDP-118 Vehicle Cream | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 13.81 | 49.5 years STANDARD_DEVIATION 13.47 | 48.3 years STANDARD_DEVIATION 11.63 | 52.5 years STANDARD_DEVIATION 9.37 | 50.36 years STANDARD_DEVIATION 13.06 |
| Sex: Female, Male Female | 29 Participants | 21 Participants | 6 Participants | 6 Participants | 62 Participants |
| Sex: Female, Male Male | 32 Participants | 42 Participants | 10 Participants | 8 Participants | 92 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 | 1 / 61 | 0 / 62 | 0 / 15 | 1 / 14 |
| serious Total, serious adverse events | 0 / 61 | 0 / 62 | 0 / 15 | 0 / 14 |
Outcome results
Primary
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).
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-118 Lotion | Percent of Subjects With Treatment Success | 32.79 percentage of participants |
| Ultravate Cream | Percent of Subjects With Treatment Success | 33.97 percentage of participants |
| IDP-118 Vehicle Lotion | Percent of Subjects With Treatment Success | 0 percentage of participants |
| IDP-118 Vehicle Cream | Percent of Subjects With Treatment Success | 7.14 percentage of participants |