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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.
Clinical Trial for each subject is approximately 14 weeks and are randomized to one of the two treatments for 12 weeks. Subjects must be 9 years of age and older 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 for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Success Rate at Week 12 | 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 |
|---|---|---|
| Jerry Tan, MD | Windsor Clinical Research | Principal Investigator |
| Ulrike Blume-Peytavi, MD | Charité Universitätsmedizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (8258) | Mobile | Alabama | 36608 | United States | ||
| Galderma Investigational Site (# 8530) |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD5789 (Trifarotene) 50μg/g Cream | CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks. |
| FG001 | Placebo Cream | Placebo cream applied once daily for 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 | Apr 17, 2019 |
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| Placebo cream | Drug | Placebo cream applied once daily for 12 weeks |
|
| Glendale |
| Arizona |
| 85308 |
| United States |
| Galderma Investigational Site (# 8511) | Phoenix | Arizona | 85018 | United States |
| Galderma Investigational Site (# 8009) | Hot Springs | Arkansas | 71913 | United States |
| Galderma Investigational Site (# 8355) | Rogers | Arkansas | 72758 | United States |
| Galderma Investigational Site (# 8456) | Beverly Hills | California | 90212 | United States |
| Galderma Investigational site (8578) | Cerritos | California | 90703 | United States |
| Galderma Investigational Site (# 8526) | Clovis | California | 93612 | United States |
| Galderma Investigational Site (8577) | Encinitas | California | 92024 | United States |
| Galderma Investigational Site (# 8224) | Fremont | California | 94538 | United States |
| Galderma Investigational Site (# 8509) | Fullerton | California | 92835 | United States |
| Galderma Investigational Site (# 8507) | Huntington Beach | California | 92647 | United States |
| Galderma Investigational Site (# 8425) | Newport Beach | California | 92663 | United States |
| Galderma Investigational Site (# 8052) | Oceanside | California | 92056 | United States |
| Galderma Investigational Site (# 8528) | Santa Ana | California | 92701 | United States |
| Galderma Investigational Site (# 8160) | Santa Monica | California | 91301 | United States |
| Galderma Investigational Site (# 8443) | Temecula | California | 92592 | United States |
| Galderma Investigational Site (8572) | Colorado Springs | Colorado | 80920 | United States |
| Galderma Investigational Site (# 8510) | Englewood | Colorado | 80113 | United States |
| Galderma Investigational Site (# 8370) | Boynton Beach | Florida | 33437 | United States |
| Galderma Investigational Site (# 8543) | Fort Lauderdale | Florida | 33316 | United States |
| Galderma Investigational Site (8143) | Miami | Florida | 33175 | United States |
| Galderma Investigational site (8259) | Miramar | Florida | 33027 | United States |
| Galderma Investigational Site (# 8522) | North Miami Beach | Florida | 33162 | United States |
| Galderma Investigational Site (# 8531) | Orange Park | Florida | 32073 | United States |
| Galderma Investigational Site (8502) | Orlando | Florida | 32814 | United States |
| Galderma Investigational Site (#8213) | Ormond Beach | Florida | 32174 | United States |
| Galderma Investigational Site (# 8529) | Sanford | Florida | 32771 | United States |
| Galderma Investigational Site (# 8455) | St. Petersburg | Florida | 33708 | United States |
| Galderma Investigational Site (# 8523) | Tampa | Florida | 33609 | United States |
| Galderma Investigational Site (# 8126) | West Palm Beach | Florida | 33401 | United States |
| Galderma Investigational Site (#8189) | Snellville | Georgia | 30078 | United States |
| Galderma Investigational Site (8582) | Idaho Falls | Idaho | 83404 | United States |
| Galderma Investigational Site (# 8367) | Arlington Heights | Illinois | 60005 | United States |
| Galderma Investigational Site (8191) | Chicago | Illinois | 60611 | United States |
| Galderma Investigational site (8571) | Darien | Illinois | 60561 | United States |
| Galderma Investigational Site (8575) | Oakbrook Terrace | Illinois | 60180 | United States |
| Galderma Investigational Site (# 8366) | Plainfield | Indiana | 46168 | United States |
| Galderma Investigational Site (# 8532) | Overland Park | Kansas | 66215 | United States |
| Galderma Investigational Site (# 8069) | Louisville | Kentucky | 40202 | United States |
| Galderma Investigational Site (8092) | Louisville | Kentucky | 40217 | United States |
| Galderma Investigational Site (8545) | Owensboro | Kentucky | 42301 | United States |
| Galderma Investigational Site (8457) | Monroe | Louisiana | 71203 | United States |
| Galderma Investigational site (8580) | New Orleans | Louisiana | 70130 | United States |
| Galderma Investigational Site (# 8012) | Glenn Dale | Maryland | 20769 | United States |
| Galderma Investigational Site (# 8525) | Rockville | Maryland | 20850 | United States |
| Galderma Investigational Site (# 8541) | Quincy | Massachusetts | 02169 | United States |
| Galderma Investigational Site (#8512) | Bay City | Michigan | 48706 | United States |
| Galderma Investigational Site (8574) | Clarkston | Michigan | 48346 | United States |
| Galderma Investigational Site (#8033) | Clinton Township | Michigan | 48038 | United States |
| Galderma Investigational Site (8129) | Fort Gratiot | Michigan | 48059 | United States |
| Galderma Investigational Site (# 8226) | Warren | Michigan | 48088 | United States |
| Galderma Investigational Site (# 8521) | Saint Joseph | Missouri | 64506 | United States |
| Galderma Investigational Site (#8027) | St Louis | Missouri | 63141 | United States |
| Galderma Investigational Site (# 8544) | Lincoln | Nebraska | 68502 | United States |
| Galderma Investigational Site (# 8108) | Las Vegas | Nevada | 89144 | United States |
| Galderma Investigational Site (#8420) | Newington | New Hampshire | 03801 | United States |
| Galderma Investigational Site (# 8506) | Hackensack | New Jersey | 07601 | United States |
| Galderma Investigational Site (#8500) | Brooklyn | New York | 11203 | United States |
| Galderma Investigational Site (8524) | East Setauket | New York | 11733 | United States |
| Galderma Investigational Site (8568) | New York | New York | 10022 | United States |
| Galderma Investigational Site (8585) | New York | New York | 10028 | United States |
| Galderma Investigational Site (8279) | New York | New York | 10075 | United States |
| Galderma Investigational Site (8566) | Charlotte | North Carolina | 28277 | United States |
| Galderma Investigational Site (#8514) | Hickory | North Carolina | 28602 | United States |
| Galderma Investigational Site (# 8195) | Beachwood | Ohio | 44122 | United States |
| Galderma Investigational Site (# 8016) | Cincinnati | Ohio | 45255 | United States |
| Galderma Investigational site (8595) | Dublin | Ohio | 43016 | United States |
| Galderma Investigational Site (8188) | Hershey | Pennsylvania | 17033 | United States |
| Galderma Investigational site (8353) | Yardley | Pennsylvania | 19067 | United States |
| Galderma Investigational Site (# 8369) | Charleston | South Carolina | 29414 | United States |
| Galderma Investigational Site (# 8117) | Knoxville | Tennessee | 37917 | United States |
| Galderma Investigational Site (# 8515) | Nashville | Tennessee | 37203 | United States |
| Galderma Investigational Site (# 8542) | Arlington | Texas | 76017 | United States |
| Galderma Investigational Site (#8513) | Austin | Texas | 78705 | United States |
| Galderma Investigational site (8579) | Beaumont | Texas | 77701 | United States |
| Galderma Investigational Site (# 8245) | Dallas | Texas | 75231 | United States |
| Galderma Investigational Site (8183) | Houston | Texas | 77030 | United States |
| Galderma Investigational site (8576) | Katy | Texas | 77949 | United States |
| Galderma Investigational Site (8583) | Murphy | Texas | 75094 | United States |
| Galderma Investigational Site (8567) | San Antonio | Texas | 78213 | United States |
| Galderma Investigational site (8433) | San Antonio | Texas | 78218 | United States |
| Galderma Investigational site (8329) | San Antonio | Texas | 78229 | United States |
| Galderma Investigational site (8106) | Layton | Utah | 84041 | United States |
| Galderma Investigational Site (# 8214) | Salt Lake City | Utah | 84117 | United States |
| Galderma Investigational Site (# 8351) | Seattle | Washington | 98104 | United States |
| Galderma Investigational Site (# 8215) | Calgary | Alberta | T3A 2N1 | Canada |
| Galderma Investigational site (8161) | Surrey | British Columbia | V3V 0C6 | Canada |
| Galderma Investigational Site (# 8154) | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Galderma Investigational Site (8586) | Barrie | Ontario | L4M 7G1 | Canada |
| Galderma Investigational Site (# 8038) | Hamilton | Ontario | L8N 1V6 | Canada |
| Galderma Investigational Site (# 8426) | London | Ontario | N5X 2P1 | Canada |
| Galderma Investigational Site (# 8026) | Markham | Ontario | L3P 1X2 | Canada |
| Galderma Investigational Site (# 8135) | North Bay | Ontario | P1B 3Z7 | Canada |
| Galderma Investigational Site (# 8168) | Oakville | Ontario | L6J 7W5 | Canada |
| Galderma Investigational Site (# 8340) | Peterborough | Ontario | K9J 5K2 | Canada |
| Galderma Investigational Site (# 8338) | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Galderma Investigational Site (8001) | Waterloo | Ontario | N2J 1C4 | Canada |
| Galderma Investigational Site (# 8060) | Windsor | Ontario | N8W 5L7 | Canada |
| Galderma Investigational Site (5566) | Augsburg | 86179 | Germany |
| Galderma Investigational Site (5604) | Berlin | 10117 | Germany |
| Galderma Investigational Site (5815) | Berlin | 13507 | Germany |
| Galderma Investigational Site (5750) | Darmstadt | 64283 | Germany |
| Galderma Investigational Site (5572) | Dessau | 6847 | Germany |
| Galderma Investigational Site (5204) | Dresden | 1097 | Germany |
| Galderma Investigational Site (5434) | Dresden | 1307 | Germany |
| Galderma Investigational Site (5146) | Eberstadt | 64297 | Germany |
| Galderma Investigational Site (5838) | Hamburg | 20354 | Germany |
| Galderma Investigational Site (5635) | Langenau | 89129 | Germany |
| Galderma Investigational Site (5543) | Mainz | 55131 | Germany |
| Galderma Investigational Site (5307) | Münster | 48149 | Germany |
| Galderma Investigational Site (5802) | Balatonfüred | 08230 | Hungary |
| Galderma Investigational Site (5567) | Budapest | 01036 | Hungary |
| Galderma Investigational Site (5812) | Budapest | 01125 | Hungary |
| Galderma Investigational Site (5685) | Cegléd | 02700 | Hungary |
| Galderma Investigational Site (5254) | NyÃregyháza | 4400 | Hungary |
| Galderma Investigational Site (5811) | Pécel | 02119 | Hungary |
| Galderma Investigational Site (5263) | Püspökladány | 4150 | Hungary |
| Galderma Investigational Site (5237) | Szeged | 6720 | Hungary |
| Galderma Investigational Site (5767) | Szekszà rd | 07100 | Hungary |
| Galderma Investigational Site (8592) | Aibonito | 705 | Puerto Rico |
| Galderma Investigational Site (8594) | Caguas | 727 | Puerto Rico |
| Galderma Investigational site (8100) | Carolina | 985 | Puerto Rico |
| Galderma Investigational Site (8593) | San Juan | 00909-3004 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD5789 (Trifarotene) 50μg/g Cream | CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks. |
| BG001 | Placebo Cream | Placebo cream applied once daily for 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 | Number | participants |
| ||||||||||||||||||
| Physician Global Assessment Scale Face | 0 - Clear (Clear skin with no inflammatory or non-inflammatory lesions.)
| 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 | Investigator Global Assessment (IGA) Success Rate at Week 12 | 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 for 12 weeks. | 0 | 612 | 4 | 612 | 177 | 612 |
| EG001 | Placebo Cream | Placebo cream applied once daily for 12 weeks | 0 | 596 | 2 | 596 | 74 | 596 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Bones Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hereditary angioedema | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Procedural dizziness | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Infectious Mononucleosis | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Atypical Pneumonia | 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 |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Application Site Irritation | General disorders | Non-systematic Assessment |
| ||
| Application Site Pruritis | General disorders | Non-systematic Assessment |
| ||
| Skin Irritation | 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 |
| ||
| Sinusitis | 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_000.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 |
|
| Puerto Rico |
|
| Hungary |
|
| United States |
|
| Germany |
|
| Almost Clear |
|
| Mild |
|
| Moderate |
|
| Severe |
|