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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 | Lotion |
|
| IDP-118 Vehicle Lotion | Active Comparator | Vehicle Lotion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-118 Lotion | Drug | Lotion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Treatment Success at Week 8 | Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | 12 weeks |
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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 3 | Mobile | Alabama | 36601 | United States | ||
| Valeant Site 9 |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-118 Lotion | Lotion IDP-118 Lotion: Lotion |
| FG001 | IDP-118 Vehicle Lotion | Vehicle Lotion IDP-118 Vehicle Lotion: Lotion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| IDP-118 Vehicle Lotion |
| Drug |
Lotion |
|
|
| Beverly Hills |
| California |
| 90210 |
| United States |
| Valeant Site 12 | Encino | California | 91316 | United States |
| Valeant Site 10 | San Diego | California | 92093 | United States |
| Valeant Site 1 | Santa Rosa | California | 95403 | United States |
| Valeant Site 16 | Denver | Colorado | 80123 | United States |
| Valeant Site 2 | Tampa | Florida | 33601 | United States |
| Valeant Site 7 | South Bend | Indiana | 46601 | United States |
| Valeant Site 8 | Louisville | Kentucky | 40202 | United States |
| Valeant Site 13 | Clinton Township | Michigan | 48036 | United States |
| Valeant Site 14 | Rochester | New York | 14603 | United States |
| Valeant Site 6 | Nashville | Tennessee | 37115 | United States |
| Valeant Site 5 | Austin | Texas | 73344 | United States |
| Valeant Site 4 | Houston | Texas | 77001 | United States |
| Valeant Site 11 | Norfolk | Virginia | 23501 | United States |
| Valeant Site 15 | Spokane | Washington | 99201 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-118 Lotion | Lotion IDP-118 Lotion: Lotion |
| BG001 | IDP-118 Vehicle Lotion | Vehicle Lotion IDP-118 Vehicle Lotion: Lotion |
| BG002 | 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 | The Percentage of Participants With Treatment Success at Week 8 | Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Posted | Number | percentage of participants | 8 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 | Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Posted | Number | percentage of participants | 12 weeks |
|
|
12 weeks
Safety analysis set included all participants who were randomized, 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 | Lotion IDP-118 Lotion: Lotion | 3 | 133 | 7 | 133 | ||
| EG001 | IDP-118 Vehicle Lotion | Vehicle Lotion IDP-118 Vehicle Lotion: Lotion | 0 | 67 | 0 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis staphylococcal | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Contract sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | anya.loncaric@bauschhealth.com |
| Male |
|
|