Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 0454 | Other Identifier | Fougera Pharmaceuticals Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) |
|
| Reference | Active Comparator | TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) |
|
| Placebo | Placebo Comparator | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazarotene Cream 0.1% | Drug | Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Lesion Counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | Week 12 |
| Change in Non-inflammatory Lesion Counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response of Success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Angela C. Kaplan | Fougera Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fougera Investigational Site | Tucson | Arizona | 85712 | United States | ||
| Fougera Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
1154 subjects were screened for study participation, 1110 subjects were randomized and included in the statistical analyses.
25 investigative sites randomized subjects into the study.
At Baseline Visit eligible subjects were randomized to the Test, Reference or Placebo product in a 2:2:1 ratio using an interactive response technology (IRT) system
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test | Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) |
| FG001 | Reference | TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | May 31, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Tazorac® | Drug | Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days. |
|
|
| Placebo | Drug | Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days. |
|
|
| Conway |
| Arkansas |
| 72034 |
| United States |
| Fougera Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| Fougera Investigational Site | Anaheim | California | 92801 | United States |
| Fougera Investigational Site | La Mesa | California | 91942 | United States |
| Fougera Investigational Site | Long Beach | California | 90806 | United States |
| Fougera Investigational Site | Long Beach | California | 90813 | United States |
| Fougera Investigational Site | Los Angeles | California | 90010 | 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 | Upland | California | 91786 | United States |
| Fougera Investigational Site | West Covina | California | 91790 | United States |
| Fougera Investigational Site | Coral Gables | Florida | 33134 | United States |
| Fougera Investigational Site | Miami | Florida | 33015 | 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 | Plainfield | Indiana | 46168 | United States |
| Fougera Investigational Site | High Point | North Carolina | 27262 | United States |
| Fougera Investigational Site | Hazleton | Pennsylvania | 18201 | United States |
| Fougera Investigational Site | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Fougera Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| Fougera Investigational Site | Austin | Texas | 78759 | United States |
| FG002 | Placebo | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) |
|
| Modified ITT (mITT) |
|
| Per Protocol (PP) Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Test | Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) |
| BG001 | Reference | TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) |
| BG002 | Placebo | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) |
| BG003 | 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 | Started (Safety Population) | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Started (Safety Population) | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Started (Safety Population) | Number | 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 | Change in Inflammatory Lesion Counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | mITT for superiority versus placebo, PP for equivalence versus Reference | Posted | Least Squares Mean | Standard Error | percent change | Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response of Success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | mITT | Posted | Number | percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Non-inflammatory Lesion Counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | mITT for superiority versus placebo, PP for equivalence versus Reference | Posted | Least Squares Mean | Standard Error | percent change | Week 12 |
|
|
From baseline to week 12 (end of study)
Not provided
Not provided
| 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 0.1% (Fougera Pharmaceuticals Inc.) | 0 | 442 | 1 | 442 | 45 | 442 |
| EG001 | Reference | TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) | 0 | 445 | 0 | 445 | 57 | 445 |
| EG002 | Placebo | Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) | 0 | 223 | 0 | 223 | 12 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dryness | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Application site exfoliation | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
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 | May 31, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C086827 | tazarotene |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| ANOVA |
with treatment and site as fixed effects in the model |
| 0.0185 |
| Mean Difference (Final Values) |
| -5.17 |
| 2-Sided |
| 95 |
| -9.46 |
| -0.87 |
| Superiority |
|
|
|