A Phase 3 interventional study of IDP-118 Lotion in Plaque Psoriasis, sponsored by Bausch Health Americas, Inc.. Completed at 46 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Bausch Health Americas, Inc. · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 555 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
Drug: IDP-118 Lotion
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
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
| Milestone | IDP-18 Lotion |
|---|---|
| Started | 555 |
| Safety population | 550 |
| Completed | 136 |
| Not completed | 419 |
| Withdrew: Sponsor request | 39 |
| Withdrew: Withdrawal by subject | 87 |
| Withdrew: Lost to follow-up | 41 |
| Withdrew: Lack of efficacy | 151 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Protocol violation | 6 |
| Withdrew: Adverse event | 33 |
| Withdrew: Worsening condition | 16 |
| Withdrew: Other than specified | 45 |
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.
| percentage of participants | IDP-118 Lotion |
|---|---|
| Itching | 22.2 |
| Dryness | 6.9 |
| Burning/stinging | 9.8 |
Collected over Baseline up to Week 52. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IDP-118 Lotion | 0/550 (0%) | 18/550 (3.3%) | 131/550 (23.8%) |
| Event | IDP-118 Lotion |
|---|---|
| Cellulitis gangrenousInfections and infestations | 1/550 |
| DiverticulitisInfections and infestations | 1/550 |
| SepsisInfections and infestations | 1/550 |
| TonsillitisInfections and infestations | 1/550 |
| Colitis ulcerativeGastrointestinal disorders | 1/550 |
| Incarcerated umbilical herniaGastrointestinal disorders | 1/550 |
| Pancreatitis acuteGastrointestinal disorders | 1/550 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/550 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/550 |
| Small intestine adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/550 |
| Event | IDP-118 Lotion |
|---|---|
| Application site dermatitisGeneral disorders | 59/550 |
| Application site pruritusGeneral disorders | 33/550 |
| Application site painGeneral disorders | 29/550 |
| NasopharyngitisInfections and infestations | 28/550 |
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
| Age, Continuous(Years) | IDP-118 Lotion |
|---|---|
| Mean | 51.9 ± 14.06 |
| Sex: Female, Male(Participants) | IDP-118 Lotion |
|---|---|
| Female | 189 |
| Male | 361 |
| Ethnicity (NIH/OMB)(Participants) | IDP-118 Lotion |
|---|---|
| Hispanic or Latino | 141 |
| Not Hispanic or Latino | 409 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | IDP-118 Lotion |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 15 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 46 |
| White | 473 |
| More than one race | 0 |
| Unknown or Not Reported | 12 |
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Bausch Health Americas, Inc.