Plaque Psoriasis
Conditions
Brief summary
The objective of the study is to evaluate the safety and efficacy of a topical lotion
Detailed description
The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.
Interventions
DRUGIDP-118 Lotion
Lotion
DRUGIDP-118 Monad HP Lotion
Active Comparator
DRUGIDP-118 Monad Taz Lotion
Active Comparator
Vehicle
Sponsors
Dow Pharmaceutical Sciences
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 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 |
|---|---|---|
| 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 8 | 8 weeks | Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to clear or almost clear at Week 8. 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). |
| 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 Weeks 2, 4, 6, and 12 | Weeks 2, 4, 6, and 12 (4-week follow-up) | 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 Weeks 2, 4, 6, and 12. 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 halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Lotion: Lotion | 59 |
| IDP-118 Monad HP Lotion HP
IDP-118 Monad HP Lotion: Active Comparator | 63 |
| IDP-118 Monad Taz Lotion Taz
IDP-118 Monad Taz Lotion: Active Comparator | 59 |
| IDP-118 Vehicle Lotion Vehicle
IDP-118 Vehicle Lotion: Vehicle | 31 |
| Total | 212 |
Baseline characteristics
| Characteristic | IDP-118 Lotion | IDP-118 Monad HP Lotion | IDP-118 Monad Taz Lotion | IDP-118 Vehicle Lotion | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 13.7 | 54.2 years STANDARD_DEVIATION 11.52 | 55.7 years STANDARD_DEVIATION 13.1 | 52.4 years STANDARD_DEVIATION 16.11 | 52.66 years STANDARD_DEVIATION 13.55 |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 19 Participants | 12 Participants | 79 Participants |
| Sex: Female, Male Male | 35 Participants | 39 Participants | 40 Participants | 19 Participants | 133 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 | 7 / 59 | 0 / 62 | 9 / 58 | 4 / 31 |
| serious Total, serious adverse events | 0 / 59 | 1 / 62 | 1 / 58 | 2 / 31 |
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 8
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to clear or almost clear at Week 8. 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: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-118 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 8 | 52.5 percentage of participants |
| IDP-118 Monad HP 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 8 | 33.3 percentage of participants |
| IDP-118 Monad Taz 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 8 | 18.6 percentage of participants |
| IDP-118 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 8 | 9.7 percentage of participants |
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 Weeks 2, 4, 6, and 12
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 Weeks 2, 4, 6, and 12. 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: Weeks 2, 4, 6, and 12 (4-week follow-up)
Population: The number of participants with IGA results at each visit were utilized in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 6 | 32.2 percentage of participants |
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 2 | 11.9 percentage of participants |
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 4 | 25.4 percentage of participants |
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 12 | 38.2 percentage of participants |
| IDP-118 Monad HP 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 Weeks 2, 4, 6, and 12 | Week 12 | 21.0 percentage of participants |
| IDP-118 Monad HP 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 Weeks 2, 4, 6, and 12 | Week 6 | 25.4 percentage of participants |
| IDP-118 Monad HP 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 Weeks 2, 4, 6, and 12 | Week 2 | 4.8 percentage of participants |
| IDP-118 Monad HP 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 Weeks 2, 4, 6, and 12 | Week 4 | 17.5 percentage of participants |
| IDP-118 Monad Taz 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 Weeks 2, 4, 6, and 12 | Week 4 | 1.7 percentage of participants |
| IDP-118 Monad Taz 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 Weeks 2, 4, 6, and 12 | Week 2 | 1.7 percentage of participants |
| IDP-118 Monad Taz 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 Weeks 2, 4, 6, and 12 | Week 6 | 15.3 percentage of participants |
| IDP-118 Monad Taz 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 Weeks 2, 4, 6, and 12 | Week 12 | 12.8 percentage of participants |
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 4 | 6.5 percentage of participants |
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 2 | 0 percentage of participants |
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 12 | 6.9 percentage of participants |
| IDP-118 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 Weeks 2, 4, 6, and 12 | Week 6 | 3.2 percentage of participants |