Psoriasis
Conditions
Brief summary
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Detailed description
A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) 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. * Has an area of plaque psoriasis appropriate for topical treatment that covers a Body Surface Area (BSA) 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) Investigator 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.) 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, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear. | 12 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 | 62 |
| Tazorac Cream Cream
Tazorac Cream: Cream | 58 |
| IDP 118 Vehicle Lotion Lotion
IDP-118 Vehicle Lotion: Lotion | 15 |
| IDP-118 Vehicle Cream Cream
IDP-118 Vehicle Cream: Cream | 17 |
| Total | 152 |
Baseline characteristics
| Characteristic | IDP-118 Lotion | Tazorac Cream | IDP 118 Vehicle Lotion | IDP-118 Vehicle Cream | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 14.58 | 48.4 years STANDARD_DEVIATION 12.37 | 48.9 years STANDARD_DEVIATION 14.78 | 56.8 years STANDARD_DEVIATION 11.92 | 49.81 years STANDARD_DEVIATION 13.61 |
| Sex: Female, Male Female | 20 Participants | 24 Participants | 7 Participants | 5 Participants | 56 Participants |
| Sex: Female, Male Male | 42 Participants | 34 Participants | 8 Participants | 12 Participants | 96 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 | 10 / 60 | 8 / 57 | 4 / 15 | 0 / 16 |
| serious Total, serious adverse events | 1 / 60 | 1 / 57 | 0 / 15 | 0 / 16 |
Outcome results
Primary
Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.
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: 12 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-118 Lotion | Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear. | 31.66 percentage of participants |
| Tazorac Cream | Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear. | 13.77 percentage of participants |
| IDP 118 Vehicle Lotion | Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear. | 15.90 percentage of participants |
| IDP-118 Vehicle Cream | Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear. | 7.96 percentage of participants |