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| ID | Type | Description | Link |
|---|---|---|---|
| 0453 | Other Identifier | Fougera Pharmaceuticals Inc. |
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A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) |
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| Reference | Active Comparator | TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) |
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| Placebo | Placebo Comparator | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazarotene Cream 0.05% | Drug | Tazarotene Cream 0.05% to cover only the lesions with a thin film. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success Assessed by IGA | Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Severity None or Minimal on IGA | Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study). | Week 12 |
| Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela C. Kaplan | Fougera Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fougera Investigational Site | Phoenix | Arizona | 85018 | United States | ||
| Fougera Investigational Site |
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927 subjects were screened for study participation, 855 subjects were randomized and included in the statistical analyses.
29 investigative sites (one with two locations) randomized subjects into the study.
At Visit 1, eligible subjects were randomized to the Test, Reference or Placebo product in a 1:1:1 ratio using an interactive response technology (IRT) system.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) |
| FG001 | Reference | TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) |
| 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 | Yes | No | No | Study Protocol | Dec 22, 2016 | Jul 30, 2018 |
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| TAZORAC® (tazarotene) Cream 0.05% | Drug | TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film. |
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| Placebo | Drug | Placebo (vehicle of the test product) to cover only the lesions with a thin film. |
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Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study). |
| Week 12 |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Fougera Investigational Site | Anaheim | California | 92801 | United States |
| Fougera Investigational Site | North Hollywood | California | 91606 | United States |
| Fougera Investigational Site | San Diego | California | 92108 | United States |
| Fougera Investigational Site | San Ramon | California | 94582 | United States |
| Fougera Investigational Site | Brandon | Florida | 33511 | United States |
| Fougera Investigational Site | Coral Gables | Florida | 33134 | United States |
| Fougera Investigational Site | Hialeah | Florida | 33016 | United States |
| Fougera Investigational Site | Miami | Florida | 33015 | United States |
| Fougera Investigational Site | Miami | Florida | 33143 | United States |
| Fougera Investigational Site | Miami | Florida | 33175 | United States |
| Fougera Investigational Site | Miami Gardens | Florida | 33169 | United States |
| Fougera Investigational Site | Miramar | Florida | 33027 | United States |
| Fougera Investigational Site | Sweetwater | Florida | 33172 | United States |
| Fougera Investigational Site | Tampa | Florida | 33618 | United States |
| Fougera Investigational Site | West Palm Beach | Florida | 33406 | United States |
| Fougera Investigational Site | Macon | Georgia | 31217 | United States |
| Fougera Investigational Site | Arlington Heights | Illinois | 60005 | United States |
| Fougera Investigational Site | New Albany | Indiana | 47150 | United States |
| Fougera Investigational Site | Plainfield | Indiana | 46168 | United States |
| Fougera Investigational Site | Louisville | Kentucky | 40202 | United States |
| Fougera Investigational Site | Lake Charles | Louisiana | 70605 | United States |
| Fougera Investigational Site | Saint Joseph | Missouri | 91606 | United States |
| Fougera Investigational Site | Henderson | Nevada | 89052 | United States |
| Fougera Investigational Site | High Point | North Carolina | 27262 | United States |
| Fougera Investigational Site | Salem | Oregon | 97302 | United States |
| Fougera Investigational Site | Hazleton | Pennsylvania | 18201 | United States |
| Fougera Investigational Site | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Fougera Investigational Site | San Antonio | Texas | 78207 | United States |
| FG002 | Placebo | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) |
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| Modified Intent-to Treat (mITT) | met all inclusion/exclusion criteria, received study treatment, and had a post-Baseline evaluation |
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| Per-Protocol Population (PP) | all randomized subjects who complied with the protocol |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) |
| BG001 | Reference | TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) |
| BG002 | Placebo | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Started (Safety Population) | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Started (Safety Population) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Started (Safety Population) | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Treatment Success Assessed by IGA | Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study). | mITT for superiority versus placebo, PP for equivalence versus Reference | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Disease Severity None or Minimal on IGA | Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study). | mITT | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI | Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study). | mITT | Posted | Number | Percentage of Participants | Week 12 |
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Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
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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 | Test | Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) | 0 | 284 | 0 | 284 | 31 | 284 |
| EG001 | Reference | TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) | 0 | 286 | 0 | 286 | 24 | 286 |
| EG002 | Placebo | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) | 0 | 285 | 3 | 285 | 21 | 285 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Systematic Assessment |
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| Ischaemic nephropathy | Renal and urinary disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dryness | General disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Application site erosion | General disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Application site pain | General disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Application site rash | General disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
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The terms and conditions of Fougera' agreements with its investigators may vary. However, Fougera does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela C Kaplan | Fougera Pharmaceuticals Inc. | 631-659-2256 | angela.kaplan@sandoz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2017 | Jul 30, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C086827 | tazarotene |
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| Male |
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| Not Hispanic or Latino |
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| Cochran-Mantel-Haenszel |
stratified by clinical site |
| 0.3520 |
| Superiority |
Last Observation Carried Forward (LOCF) for missing efficacy values |
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