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A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-122 Lotion | Experimental | Lotion |
|
| Ultravate Cream | Active Comparator | Cream |
|
| IDP-122 Vehicle Lotion | Active Comparator | Lotion |
|
| IDP-122 Vehicle Cream | Active Comparator | Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-122 Vehicle Lotion | Drug | Vehicle |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 2 | 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 Week 2. 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). | 2 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binu J Alexander, MD | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 05 | Rogers | Arkansas | 75758 | United States | ||
| Valeant Site 10 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207807 | Derived | Kerdel FA, Draelos ZD, Tyring SK, Lin T, Pillai R. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis. J Dermatolog Treat. 2019 Jun;30(4):333-339. doi: 10.1080/09546634.2018.1523362. Epub 2018 Nov 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-122 Lotion | Lotion IDP-122 Lotion: Lotion |
| FG001 | Ultravate Cream | Cream Ultravate Cream: Cream |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| IDP-122 Vehicle Cream | Drug | Vehicle |
|
|
| IDP-122 Lotion | Drug | Lotion |
|
|
| Ultravate Cream | Drug | Cream |
|
|
| Beverly Hills |
| California |
| 90210 |
| United States |
| Valeant Site 09 | Carlsbad | California | 92008 | United States |
| Valeant Site 13 | Los Angeles | California | 90045 | United States |
| Valeant Site 12 | Santa Monica | California | 90404 | United States |
| Valeant Site 07 | Coral Gables | Florida | 33134 | United States |
| Valeant Site 11 | North Miami Beach | Florida | 33162 | United States |
| Valeant Site 03 | Sanford | Florida | 32771 | United States |
| Valeant Site 08 | Albany | Indiana | 47150 | United States |
| Valeant Site 04 | Louisville | Kentucky | 40202 | United States |
| Valeant Site 06 | Fridley | Minnesota | 55432 | United States |
| Valeant Site 02 | High Point | North Carolina | 27262 | United States |
| Valeant Site 01 | Houston | Texas | 77065 | United States |
| FG002 |
| IDP-122 Vehicle Lotion |
Lotion IDP-122 Vehicle Lotion: Vehicle |
| FG003 | IDP-122 Vehicle Cream | Cream IDP-122 Vehicle Cream: Vehicle |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-122 Lotion | Lotion IDP-122 Lotion: Lotion |
| BG001 | Ultravate Cream | Cream Ultravate Cream: Cream |
| BG002 | IDP-122 Vehicle Lotion | Lotion IDP-122 Vehicle Lotion: Vehicle |
| BG003 | IDP-122 Vehicle Cream | Cream IDP-122 Vehicle Cream: Vehicle |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 2 | 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 Week 2. 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). | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
8 weeks
Adverse events were collected from participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-Baseline safety assessment (Safety Population).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDP-122 Lotion | Lotion IDP-122 Lotion: Lotion | 0 | 60 | 0 | 60 | ||
| EG001 | Ultravate Cream | Cream Ultravate Cream: Cream | 0 | 57 | 0 | 57 | ||
| EG002 | IDP-122 Vehicle Lotion | Lotion IDP-122 Vehicle Lotion: Vehicle | 0 | 15 | 1 | 15 | ||
| EG003 | IDP-122 Vehicle Cream | Cream IDP-122 Vehicle Cream: Vehicle | 0 | 16 | 0 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site warmth | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | anya.loncaric@bauschhealth.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C064466 | halobetasol |
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| Male |
|