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Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.
To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD5789 (trifarotene) cream | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD5789 (trifarotene) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Success Rate up to Week 52 | Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear). | From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessment (PGA) Success Rate up to Week 52 | Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear). | From Baseline to Week 52 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Chan | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Galderma Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD5789 Cream | CD5789 Trifarotene 50 microgram/gram cream |
| 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 | Aug 7, 2014 | Apr 17, 2019 |
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| Rogers |
| Arkansas |
| 72758 |
| United States |
| Galderma Investigational Site | Sacramento | California | 95819 | United States |
| Galderma Investigational Site | San Diego | California | 92123 | United States |
| Galderma Investigational Site | Miami | Florida | 33175 | United States |
| Galderma Investigational Site | Miramar | Florida | 33027 | United States |
| Galderma Investigational Site | Newnan | Georgia | 30277 | United States |
| Galderma Investigational Site | Louisville | Kentucky | 40241 | United States |
| Galderma Investigational Site | Albuquerque | New Mexico | 87107 | United States |
| Galderma Investigational Site | New York | New York | 10155 | United States |
| Galderma Investigational Site | High Point | North Carolina | 27262 | United States |
| Galderma Investigational Site | Beachwood | Ohio | 44122 | United States |
| Galderma Investigational Site | Portland | Oregon | 97210 | United States |
| Galderma Investigational Site | Knoxville | Tennessee | 37922 | United States |
| Galderma Investigational Site | Chomutov | 430 04 | Czechia |
| Galderma Investigational site | Hradec Králové | 500 05 | Czechia |
| Galderma Investigational Site | Olomouc | 775 20 | Czechia |
| Galderma Investigational Site | Pardubice | 532 03 | Czechia |
| Galderma Investigational site | Prague | 110 00 | Czechia |
| Galderma Investigational Site | Augsburg | 86179 | Germany |
| Galderma Investigational Site | Berlin | 10117 | Germany |
| Galderma Investigational Site | Berlin | 13507 | Germany |
| Galderma Investigational Site | Dessau | 06847 | Germany |
| Galderma Investigational Site | Mahlow | 15831 | Germany |
| Galderma Investigational Site | Münster | 48149 | Germany |
| Galderma Investigational Site | Wuppertal | 42287 | Germany |
| Galderma Investigational Site | Balatonfüred | 8230 | Hungary |
| Galderma Investigational Site | Miskolc | 3529 | Hungary |
| Galderma Investigational Site | Pécel | 2119 | Hungary |
| Galderma Investigational Site | Szeged | 6720 | Hungary |
| Galderma Investigational Site | Szekszárd | 7100 | Hungary |
| Galderma Investigational Site | Szolnok | 5000 | Hungary |
| COMPLETED |
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| NOT COMPLETED |
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A total of 455 subjects were enrolled and 453 were exposed to CD5789 50 microgram/gram cream for up to 52 weeks.
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| ID | Title | Description |
|---|---|---|
| BG000 | CD5789 Cream | CD5789 Trifarotene 50 microgram/gram |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Investigator Global Assessment (IGA) Success Rate up to Week 52 | Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear). | A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram. | Posted | Count of Participants | Participants | From Baseline to Week 52 |
|
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| ||||||||||||||||||||||||||
| Secondary | Physician Global Assessment (PGA) Success Rate up to Week 52 | Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear). | A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram | Posted | Count of Participants | Participants | From Baseline to Week 52 |
|
|
Over 52 Weeks
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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 | CD5789 Cream | CD5789 Trifarotene 50 microgram/gram | 0 | 453 | 10 | 453 | 170 | 453 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Umbilical Hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyelonephritis Acute | Infections and infestations | Non-systematic Assessment |
| ||
| Complex partial seizures | Nervous system disorders | Non-systematic Assessment |
| ||
| Complex regional Pain syndrome | Nervous system disorders | Non-systematic Assessment |
| ||
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Liver function test abnormal | Investigations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sunburn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ligament Sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Application Site Pruritis | General disorders | Non-systematic Assessment |
| ||
| Application Site Irritation | General disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Infectious Mononucleosis | Infections and infestations | Non-systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
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All data or results arising out of the study will not be presented or published in any form or media by the PI/Institution without the prior written consent of sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Fulton | Galderma S.A. | +1 817-961-5203 | anne.fulton@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2015 | Nov 12, 2019 | SAP_002.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D019066 | Facies |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629420 | trifarotene |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Czechia |
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| Germany |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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