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Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD5789 (Trifarotene) 50µg/g Cream | Experimental | CD5789 (trifarotene) 50µg/g Cream |
|
| Placebo Cream | Placebo Comparator | Placebo Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD5789 (trifarotene) 50µg/g Cream | Drug | CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12. | From Baseline to Week 12 |
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Inclusion Criteria:
Exclusion 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 | Birmingham | Alabama | 35205 | United States | ||
| Galderma Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD5789 (Trifarotene) 50µg/g Cream | CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks. |
| FG001 | Placebo Cream | Placebo cream applied once daily during 12 weeks. |
| 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 | Mar 10, 2017 | Aug 5, 2019 |
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| Placebo Cream | Drug | Placebo cream applied once daily during 12 weeks. |
|
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Galderma Investigational Site | Tucson | Arizona | 85712 | United States |
| Galderma Investigational Site | Fort Smith | Arkansas | 72916 | United States |
| Galderma Investigational Site | Los Angeles | California | 90036 | United States |
| Galderma Investigational Site | Murrieta | California | 92562 | United States |
| Galderma Investigational Site | Santa Ana | California | 92705 | United States |
| Galderma Investigational Site | Aventura | Florida | 33180 | United States |
| Galderma Investigational Site | Miami | Florida | 33144 | United States |
| Galderma Investigational Site | Miami Lakes | Florida | 33016 | United States |
| Galderma Investigational Site | West Palm Beach | Florida | 33406 | United States |
| Galderma Investigational Site | Corbin | Kentucky | 40701 | United States |
| Galderma Investigational Site | Beverly | Massachusetts | 01915 | United States |
| Galderma Investigational Site | Ann Arbor | Michigan | 48103 | United States |
| Galderma Investigational Site | Detroit | Michigan | 48202 | United States |
| Galderma Investigational Site | Brooklyn | New York | 11203 | United States |
| Galderma Investigational Site | Stony Brook | New York | 11790 | United States |
| Galderma Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Galderma Investigational Site | Fort Washington | Pennsylvania | 19034 | United States |
| Galderma Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| Galderma Investigational Site | Greer | South Carolina | 29650 | United States |
| Galderma Investigational Site | Goodlettsville | Tennessee | 37072 | United States |
| Galderma Invetsigational site | Austin | Texas | 78759-8858 | United States |
| Galderma Investigational Site | Dallas | Texas | 75230-5806 | United States |
| Galderma Investigational Site | Houston | Texas | 77004 | United States |
| Galderma Investigational Site | Pflugerville | Texas | 78660 | United States |
| Galderma Investigational Site | San Antonio | Texas | 78249 | United States |
| Galderma Investigational Site | Webster | Texas | 77598 | United States |
| Galderma Investigational Site | Walla Walla | Washington | 99362 | United States |
| Galderma Investigational Site | Chomutov | 430 04 | Czechia |
| Galderma Investigational Site | Hradec Králové | 500 05 | Czechia |
| Galderma Investigational Site | Kutná Hora | 284 01 | Czechia |
| Galderma Investigational Site | Olomouc | 775 20 | Czechia |
| Galderma Investigational Site | Pardubice | 532 03 | Czechia |
| Galderma Investigational Site | Prague | 11 000 | Czechia |
| Galderma Investigational Site | Prague | 110 00 | Czechia |
| Galderma Investigational Site | Prague | 190 11 | Czechia |
| Galderma Investigational Site | Budapest | 1035 | Hungary |
| Galderma Investigational Site | Budapest | 1089 | Hungary |
| Galderma Investigational Site | Debrecen | 4032 | Hungary |
| Galderma Investigational Site | Miskolc | 3529 | Hungary |
| Galderma Investigational Site | Pécs | 7632 | Hungary |
| Galderma Investigational Site | Szeged | 6720 | Hungary |
| Galderma Investigational Site | Szolnok | 5000 | Hungary |
| Galderma Investigational Site | Bialystok | 15-453 | Poland |
| Galderma Investigational Site | Gdansk | 80-152 | Poland |
| Galderma Investigational Site | Gdansk | 80-402 | Poland |
| Galderma Investigational Site | Gdansk | 80-546 | Poland |
| Galderma Investigational Site | Katowice | 40-036 | Poland |
| Galderma investigational Site | Katowice | 40-611 | Poland |
| Galderma Investigational Site | Katowice | 40-851 | Poland |
| Galderma Investigational Site | Lodz | 90-242 | Poland |
| Galderma Investigational Site | Sochaczew | 95-500 | Poland |
| Galderma Investigational Site | Warsaw | 01-817 | Poland |
| Galderma investigational Site | Warsaw | 02-657 | Poland |
| Galderma Investigational Site | Warsaw | 02-758 | Poland |
| Galderma Investigational Site | Wroclaw | 51-318 | Poland |
| Galderma Investigational Site | Wroclaw | 53-658 | Poland |
| Galderma Investigational Site | Brasov | 500283 | Romania |
| Galderma Investigational Site | Craiova | 200642 | Romania |
| Galderma Investigational Site | Iași | 700381 | Romania |
| Galderma Investigational Site | Târgu Mureş | 540530 | Romania |
| Galderma Investigational Site | Krasnodar | 3500 20 | Russia |
| Galderma Investigational Site | Lipetsk | 398035 | Russia |
| Galderma Investigational Site | Moscow | 107076 | Russia |
| Galderma Investigational Site | Moscow | 119071 | Russia |
| Galderma Investigational Site | Moscow | 121614 | Russia |
| Galderma Investigational Site | Saint Petersburg | 194100 | Russia |
| Galderma Investigational Site | Sr Petersburg | 194021 | Russia |
| Galderma Investigational Site | Barcelona | 08206 | Spain |
| Galderma Investigational Site | Esplugues de Llobregat | 8950 | Spain |
| Galderma Investigational site | Madrid | 28009 | Spain |
| Galderma Investigational Site | Valencia | 46014 | Spain |
| Galderma Investigational Site | Dnipropetrovsk | 49044 | Ukraine |
| Galderma Investigational Site | Dnipropetrovsk | 49074 | Ukraine |
| Galderma Investigational Site | Ivano-Frankivsk | 76000 | Ukraine |
| Galderma Investigational Site | Kharkiv | 61057 | Ukraine |
| Galderma Investigational Site | Kyiv | 01601 | Ukraine |
| Galderma Investigational Site | Kyiv | 04209 | Ukraine |
| Galderma Investigational Site | Lviv | 79049 | Ukraine |
| Galderma Investigational Site | Uzhhorod | 88000 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD5789 (Trifarotene) 50µg/g Cream | CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks. |
| BG001 | Placebo Cream | Placebo cream applied once daily during 12 weeks. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Investigator Global Asssessment | 0 - Clear (Clear skin with no inflammatory or non-inflammatory lesions.)
| 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 | Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12. | Posted | Count of Participants | Participants | From Baseline to Week 12 |
|
|
|
Each participant's adverse events were collected starting at the first visit (screening) until the last visit (Week 12).
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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 (Trifarotene) 50µg/g Cream | CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks. | 0 | 602 | 2 | 602 | 21 | 602 |
| EG001 | Placebo Cream | Placebo cream applied once daily during 12 weeks. | 0 | 610 | 4 | 610 | 5 | 610 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ligament Sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
| ||
| Major Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sunburn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Drug Administered at Inappropriate Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Blood Bilirubin Increased | Investigations | Non-systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Non-systematic Assessment |
| ||
| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Eyelid Exfoliation | Eye disorders | Non-systematic Assessment |
| ||
| Eyelid Edema | Eye disorders | Non-systematic Assessment |
| ||
| Application Site Irritation | General disorders | Non-systematic Assessment |
| ||
| Application Site Puritis | General disorders | Non-systematic Assessment |
| ||
| Application Site Pain | General disorders | Non-systematic Assessment |
| ||
| Application Site Dryness | General disorders | Non-systematic Assessment |
| ||
| Application Site Erosion | General disorders | Non-systematic Assessment |
| ||
| Application Site Erythema | General disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Cheilitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin Fissures | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Herpes Simplex | Infections and infestations | Non-systematic Assessment |
| ||
| Tinea Versicolor | Infections and infestations | Non-systematic Assessment |
| ||
| Oral Herpes | Infections and infestations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Fulton | Galderma S.A. | +1 817-961-5203 | anne.fulton@galderma.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2015 | Oct 28, 2019 | SAP_002.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000629420 | trifarotene |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hungary |
|
| United States |
|
| Czechia |
|
| Ukraine |
|
| Poland |
|
| Russia |
|
| Spain |
|
| Almost Clear |
|
| Mild |
|
| Moderate |
|
| Severe |
|