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| Name | Class |
|---|---|
| Dow Pharmaceutical Sciences | INDUSTRY |
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The objective of the study is to evaluate the safety and efficacy of a topical lotion
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-118 Lotion | Experimental | halobetasol propionate [HP], tazarotene [Taz] |
|
| IDP-118 Monad HP Lotion | Active Comparator | HP |
|
| IDP-118 Monad Taz Lotion | Active Comparator | Taz |
|
| IDP-118 Vehicle Lotion | Active Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-118 Lotion | Drug | Lotion |
|
|
| 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 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). | 8 weeks |
| 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). | Weeks 2, 4, 6, and 12 (4-week follow-up) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binu J Alexander | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 13 | Encino | California | 91436 | United States | ||
| Valeant Site 11 |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-118 Lotion | halobetasol propionate [HP], tazarotene [Taz] IDP-118 Lotion: Lotion |
| FG001 | IDP-118 Monad HP Lotion | HP IDP-118 Monad HP Lotion: Active Comparator |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| IDP-118 Monad HP Lotion |
| Drug |
Active Comparator |
|
|
| IDP-118 Monad Taz Lotion | Drug | Active Comparator |
|
|
| IDP-118 Vehicle Lotion | Drug | Vehicle |
|
|
| San Diego |
| California |
| 92123 |
| United States |
| Valeant Site 15 | Santa Rosa | California | 95403 | United States |
| Valeant Site 10 | Augusta | Georgia | 30909 | United States |
| Valeant Site 09 | Newnan | Georgia | 30263 | United States |
| Valeant Site 08 | Louisville | Kentucky | 40217 | United States |
| Valeant Site 04 | Rockville | Maryland | 20850 | United States |
| Valeant Site 14 | Clinton Township | Michigan | 48038 | United States |
| Valeant Site 07 | Fridley | Minnesota | 55432 | United States |
| Valeant Site 01 | East Windsor | New Jersey | 08520 | United States |
| Valeant Site 03 | New York | New York | 10075 | United States |
| Valeant Site 17 | Rochester | New York | 14623 | United States |
| Valeant Site 02 | High Point | North Carolina | 27262 | United States |
| Valeant Site 05 | Austin | Texas | 78759 | United States |
| Valeant Site 06 | College Station | Texas | 77845 | United States |
| Valeant Site 16 | Salt Lake City | Utah | 84117 | United States |
| Valeant Site 18 | Lynchburg | Virginia | 24501 | United States |
| Valeant Site 12 | Norfolk | Virginia | 23507 | United States |
| FG002 | IDP-118 Monad Taz Lotion | Taz IDP-118 Monad Taz Lotion: Active Comparator |
| FG003 | IDP-118 Vehicle Lotion | Vehicle IDP-118 Vehicle Lotion: Vehicle |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-118 Lotion | halobetasol propionate [HP], tazarotene [Taz] IDP-118 Lotion: Lotion |
| BG001 | IDP-118 Monad HP Lotion | HP IDP-118 Monad HP Lotion: Active Comparator |
| BG002 | IDP-118 Monad Taz Lotion | Taz IDP-118 Monad Taz Lotion: Active Comparator |
| BG003 | IDP-118 Vehicle Lotion | Vehicle IDP-118 Vehicle Lotion: 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 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). | Posted | Number | percentage of participants | 8 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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). | The number of participants with IGA results at each visit were utilized in the analysis. | Posted | Number | percentage of participants | Weeks 2, 4, 6, and 12 (4-week follow-up) |
|
12 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-118 Lotion | halobetasol propionate [HP], tazarotene [Taz] IDP-118 Lotion: Lotion | 0 | 59 | 7 | 59 | ||
| EG001 | IDP-118 Monad HP Lotion | HP IDP-118 Monad HP Lotion: Active Comparator | 1 | 62 | 0 | 62 | ||
| EG002 | IDP-118 Monad Taz Lotion | Taz IDP-118 Monad Taz Lotion: Active Comparator | 1 | 58 | 9 | 58 | ||
| EG003 | IDP-118 Vehicle Lotion | Vehicle IDP-118 Vehicle Lotion: Vehicle | 2 | 31 | 4 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | anya.loncaric@bauschhealth.com |
| ID | Term |
|---|---|
| D000091364 | Transcriptional Coactivator with PDZ-Binding Motif Proteins |
| ID | Term |
|---|---|
| D048868 | Adaptor Proteins, Signal Transducing |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
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| Male |
|
Vehicle
IDP-118 Vehicle Lotion: Vehicle
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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