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| Name | Class |
|---|---|
| Dow Pharmaceutical Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-118 Lotion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-118 Lotion | Drug | IDP-118 lotion will be applied as per the instructions provided by the investigational center staff. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 52 |
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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 6 | Mobile | Alabama | 36603 | United States | ||
| Valeant Site 24 |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-18 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2015 |
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| Beverly Hills |
| California |
| 90210 |
| United States |
| Valeant Site 32 | Encinitas | California | 92023 | United States |
| Valeant Site 27 | Encino | California | 91436 | United States |
| Valeant Site 33 | Los Angeles | California | 90001 | United States |
| Valeant Site 43 | Los Angeles | California | 90002 | United States |
| Valeant Site 45 | Sacramento | California | 94203 | United States |
| Valeant Site 25 | San Diego | California | 92093 | United States |
| Valeant Site 4 | San Diego | California | 92093 | United States |
| Valeant Site 44 | Santa Monica | California | 90401 | United States |
| Valeant Site 36 | Santa Rosa | California | 95401 | United States |
| Valeant Site 10 | Englewood | Colorado | 80113 | United States |
| Valeant Site 3 | Boynton Beach | Florida | 33424 | United States |
| Valeant Site 28 | Coral Gables | Florida | 33134 | United States |
| Valeant Site 1 | Miami | Florida | 33101 | United States |
| Valeant Site 37 | North Miami Beach | Florida | 33160 | United States |
| Valeant Site 13 | Sanford | Florida | 32771 | United States |
| Valeant Site 41 | Snellville | Georgia | 30039 | United States |
| Valeant Site 17 | South Bend | Indiana | 46601 | United States |
| Valeant Site 12 | Olathe | Kansas | 66051 | United States |
| Valeant Site 19 | Louisville | Kentucky | 40201 | United States |
| Valeant Site 14 | Louisville | Kentucky | 40205 | United States |
| Valeant Site 35 | Clinton Township | Michigan | 48036 | United States |
| Valeant Site 34 | Detroit | Michigan | 48201 | United States |
| Valeant Site 16 | Warren | Michigan | 48088 | United States |
| Valeant Site 18 | Fridley | Minnesota | 55421 | United States |
| Valeant Site 31 | Omaha | Nebraska | 68022 | United States |
| Valeant Site 2 | East Windsor | New Jersey | 08520 | United States |
| Valeant Site 29 | New York | New York | 10001 | United States |
| Valeant Site 39 | Rochester | New York | 14603 | United States |
| Valeant Site 5 | Portland | Oregon | 97201 | United States |
| Valeant Site 11 | Philadelphia | Pennsylvania | 19019 | United States |
| Valeant Site 30 | Charleston | South Carolina | 29401 | United States |
| Valeant Site 15 | Nashville | Tennessee | 37115 | United States |
| Valeant Site 9 | Dallas | Texas | 75201 | United States |
| Valeant Site 40 | Houston | Texas | 77001 | United States |
| Valeant Site 8 | Houston | Texas | 77004 | United States |
| Valeant Site 46 | Katy | Texas | 77449 | United States |
| Valeant Site 20 | Pflugerville | Texas | 78660 | United States |
| Valeant Site 21 | San Antonio | Texas | 78201 | United States |
| Valeant Site 7 | San Antonio | Texas | 78202 | United States |
| Valeant Site 22 | Webster | Texas | 77598 | United States |
| Valeant Site 38 | Salt Lake City | Utah | 84101 | United States |
| Valeant Site 23 | Lynchburg | Virginia | 24501 | United States |
| Valeant Site 26 | Norfolk | Virginia | 23501 | United States |
| Valeant Site 42 | Spokane | Washington | 99201 | United States |
| Safety Population | All participants with >=1 confirmed dose of study drug & >=1 post-Baseline safety assessment. |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 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. | Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. | Posted | Number | percentage of participants | Baseline up to Week 52 |
|
|
|
Baseline up to Week 52
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.
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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 | 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. | 0 | 550 | 18 | 550 | 131 | 550 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis gangrenous | Infections and infestations | MedDRA v18.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v18.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v18.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.0 | Systematic Assessment |
| |
| Small intestine adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v18.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v18.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v18.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA v18.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA v18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dermatitis | General disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v18.0 | Systematic Assessment |
|
Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc. | 1-510-259-5284 | aloncaric@bauschhealth.com |
| Jan 14, 2020 |
| Prot_SAP_000.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|