Plaque Psoriasis
Conditions
Brief summary
The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
Detailed description
This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.
Interventions
DRUGIDP-118 Lotion
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
Sponsors
Dow Pharmaceutical Sciences
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 Body Surface Area (BSA) of at least 3 percent (%), 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 Investigators Global Assessment (IGA) score of 3 or 4 (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment). 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 Who Experienced Grade 3 Local Skin Reactions | Baseline up to Week 52 | Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-118 Lotion IDP-118 Lotion (HP 0.01%, Taz 0.045%) was applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year. | 550 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 33 |
| Overall Study | Lack of Efficacy | 151 |
| Overall Study | Lost to Follow-up | 41 |
| Overall Study | Other than specified | 45 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Sponsor request | 39 |
| Overall Study | Withdrawal by Subject | 87 |
| Overall Study | Worsening condition | 16 |
Baseline characteristics
| Characteristic | IDP-118 Lotion |
|---|---|
| Age, Continuous | 51.9 Years STANDARD_DEVIATION 14.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 141 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 409 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 473 Participants |
| Sex: Female, Male Female | 189 Participants |
| Sex: Female, Male Male | 361 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 550 |
| other Total, other adverse events | 131 / 550 |
| serious Total, serious adverse events | 18 / 550 |
Outcome results
Primary
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Baseline up to Week 52
Population: Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDP-118 Lotion | Percentage of Participants Who Experienced Grade 3 Local Skin Reactions | Dryness | 6.9 percentage of participants |
| IDP-118 Lotion | Percentage of Participants Who Experienced Grade 3 Local Skin Reactions | Burning/stinging | 9.8 percentage of participants |
| IDP-118 Lotion | Percentage of Participants Who Experienced Grade 3 Local Skin Reactions | Itching | 22.2 percentage of participants |