Acne Vulgaris Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
| Verified date | July 2018 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
| Status | Completed |
| Enrollment | 1208 |
| Est. completion date | November 14, 2017 |
| Est. primary completion date | November 14, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 9 Years and older |
| Eligibility |
Inclusion Criteria: - The subject is a male or female, 9 years of age or older, at Screening visit. - The Subject has moderate acne at Screening and Baseline. - The subject is a female of non childbearing potential - The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application. Exclusion Criteria: - The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.). - The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial. - The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.) - The subject is unwilling to refrain from use of prohibited medication during the clinical trial |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Galderma Investigational Site (8586) | Barrie | Ontario |
| Canada | Galderma Investigational Site (# 8215) | Calgary | Alberta |
| Canada | Galderma Investigational Site (# 8038) | Hamilton | Ontario |
| Canada | Galderma Investigational Site (# 8426) | London | Ontario |
| Canada | Galderma Investigational Site (# 8026) | Markham | Ontario |
| Canada | Galderma Investigational Site (# 8135) | North Bay | Ontario |
| Canada | Galderma Investigational Site (# 8168) | Oakville | Ontario |
| Canada | Galderma Investigational Site (# 8340) | Peterborough | Ontario |
| Canada | Galderma Investigational Site (# 8338) | Richmond Hill | Ontario |
| Canada | Galderma Investigational site (8161) | Surrey | British Columbia |
| Canada | Galderma Investigational Site (8001) | Waterloo | Ontario |
| Canada | Galderma Investigational Site (# 8060) | Windsor | Ontario |
| Canada | Galderma Investigational Site (# 8154) | Winnipeg | Manitoba |
| Germany | Galderma Investigational Site (5566) | Augsburg | |
| Germany | Galderma Investigational Site (5604) | Berlin | |
| Germany | Galderma Investigational Site (5815) | Berlin | |
| Germany | Galderma Investigational Site (5750) | Darmstadt | |
| Germany | Galderma Investigational Site (5572) | Dessau | |
| Germany | Galderma Investigational Site (5204) | Dresden | |
| Germany | Galderma Investigational Site (5434) | Dresden | |
| Germany | Galderma Investigational Site (5146) | Eberstadt | |
| Germany | Galderma Investigational Site (5838) | Hamburg | |
| Germany | Galderma Investigational Site (5635) | Langenau | |
| Germany | Galderma Investigational Site (5543) | Mainz | |
| Germany | Galderma Investigational Site (5307) | Münster | |
| Hungary | Galderma Investigational Site (5802) | Balatonfüred | |
| Hungary | Galderma Investigational Site (5567) | Budapest | |
| Hungary | Galderma Investigational Site (5812) | Budapest | |
| Hungary | Galderma Investigational Site (5685) | Cegléd | |
| Hungary | Galderma Investigational Site (5254) | Nyíregyháza | |
| Hungary | Galderma Investigational Site (5811) | Pécel | |
| Hungary | Galderma Investigational Site (5263) | Püspökladány | |
| Hungary | Galderma Investigational Site (5237) | Szeged | |
| Hungary | Galderma Investigational Site (5767) | Szekszàrd | |
| Puerto Rico | Galderma Investigational Site (8592) | Aibonito | |
| Puerto Rico | Galderma Investigational Site (8594) | Caguas | |
| Puerto Rico | Galderma Investigational site (8100) | Carolina | |
| Puerto Rico | Galderma Investigational Site (8593) | San Juan | |
| United States | Galderma Investigational Site (# 8542) | Arlington | Texas |
| United States | Galderma Investigational Site (# 8367) | Arlington Heights | Illinois |
| United States | Galderma Investigational Site (#8513) | Austin | Texas |
| United States | Galderma Investigational Site (#8512) | Bay City | Michigan |
| United States | Galderma Investigational Site (# 8195) | Beachwood | Ohio |
| United States | Galderma Investigational site (8579) | Beaumont | Texas |
| United States | Galderma Investigational Site (# 8456) | Beverly Hills | California |
| United States | Galderma Investigational Site (# 8370) | Boynton Beach | Florida |
| United States | Galderma Investigational Site (#8500) | Brooklyn | New York |
| United States | Galderma Investigational site (8578) | Cerritos | California |
| United States | Galderma Investigational Site (# 8369) | Charleston | South Carolina |
| United States | Galderma Investigational Site (8566) | Charlotte | North Carolina |
| United States | Galderma Investigational Site (8191) | Chicago | Illinois |
| United States | Galderma Investigational Site (# 8016) | Cincinnati | Ohio |
| United States | Galderma Investigational Site (8574) | Clarkston | Michigan |
| United States | Galderma Investigational Site (#8033) | Clinton Township | Michigan |
| United States | Galderma Investigational Site (# 8526) | Clovis | California |
| United States | Galderma Investigational Site (8572) | Colorado Springs | Colorado |
| United States | Galderma Investigational Site (# 8245) | Dallas | Texas |
| United States | Galderma Investigational site (8571) | Darien | Illinois |
| United States | Galderma Investigational site (8595) | Dublin | Ohio |
| United States | Galderma Investigational Site (8524) | East Setauket | New York |
| United States | Galderma Investigational Site (8577) | Encinitas | California |
| United States | Galderma Investigational Site (# 8510) | Englewood | Colorado |
| United States | Galderma Investigational Site (8129) | Fort Gratiot | Michigan |
| United States | Galderma Investigational Site (# 8543) | Fort Lauderdale | Florida |
| United States | Galderma Investigational Site (# 8224) | Fremont | California |
| United States | Galderma Investigational Site (# 8509) | Fullerton | California |
| United States | Galderma Investigational Site (# 8530) | Glendale | Arizona |
| United States | Galderma Investigational Site (# 8012) | Glenn Dale | Maryland |
| United States | Galderma Investigational Site (# 8506) | Hackensack | New Jersey |
| United States | Galderma Investigational Site (8188) | Hershey | Pennsylvania |
| United States | Galderma Investigational Site (#8514) | Hickory | North Carolina |
| United States | Galderma Investigational Site (# 8009) | Hot Springs | Arkansas |
| United States | Galderma Investigational Site (8183) | Houston | Texas |
| United States | Galderma Investigational Site (# 8507) | Huntington Beach | California |
| United States | Galderma Investigational Site (8582) | Idaho Falls | Idaho |
| United States | Galderma Investigational site (8576) | Katy | Texas |
| United States | Galderma Investigational Site (# 8117) | Knoxville | Tennessee |
| United States | Galderma Investigational Site (# 8108) | Las Vegas | Nevada |
| United States | Galderma Investigational site (8106) | Layton | Utah |
| United States | Galderma Investigational Site (# 8544) | Lincoln | Nebraska |
| United States | Galderma Investigational Site (# 8069) | Louisville | Kentucky |
| United States | Galderma Investigational Site (8092) | Louisville | Kentucky |
| United States | Galderma Investigational Site (8143) | Miami | Florida |
| United States | Galderma Investigational site (8259) | Miramar | Florida |
| United States | Galderma Investigational Site (8258) | Mobile | Alabama |
| United States | Galderma Investigational Site (8457) | Monroe | Louisiana |
| United States | Galderma Investigational Site (8583) | Murphy | Texas |
| United States | Galderma Investigational Site (# 8515) | Nashville | Tennessee |
| United States | Galderma Investigational site (8580) | New Orleans | Louisiana |
| United States | Galderma Investigational Site (8279) | New York | New York |
| United States | Galderma Investigational Site (8568) | New York | New York |
| United States | Galderma Investigational Site (8585) | New York | New York |
| United States | Galderma Investigational Site (#8420) | Newington | New Hampshire |
| United States | Galderma Investigational Site (# 8425) | Newport Beach | California |
| United States | Galderma Investigational Site (# 8522) | North Miami Beach | Florida |
| United States | Galderma Investigational Site (8575) | Oakbrook Terrace | Illinois |
| United States | Galderma Investigational Site (# 8052) | Oceanside | California |
| United States | Galderma Investigational Site (# 8531) | Orange Park | Florida |
| United States | Galderma Investigational Site (8502) | Orlando | Florida |
| United States | Galderma Investigational Site (#8213) | Ormond Beach | Florida |
| United States | Galderma Investigational Site (# 8532) | Overland Park | Kansas |
| United States | Galderma Investigational Site (8545) | Owensboro | Kentucky |
| United States | Galderma Investigational Site (# 8511) | Phoenix | Arizona |
| United States | Galderma Investigational Site (# 8366) | Plainfield | Indiana |
| United States | Galderma Investigational Site (# 8541) | Quincy | Massachusetts |
| United States | Galderma Investigational Site (# 8525) | Rockville | Maryland |
| United States | Galderma Investigational Site (# 8355) | Rogers | Arkansas |
| United States | Galderma Investigational Site (# 8521) | Saint Joseph | Missouri |
| United States | Galderma Investigational Site (#8027) | Saint Louis | Missouri |
| United States | Galderma Investigational Site (# 8455) | Saint Petersburg | Florida |
| United States | Galderma Investigational Site (# 8214) | Salt Lake City | Utah |
| United States | Galderma Investigational site (8329) | San Antonio | Texas |
| United States | Galderma Investigational site (8433) | San Antonio | Texas |
| United States | Galderma Investigational Site (8567) | San Antonio | Texas |
| United States | Galderma Investigational Site (# 8529) | Sanford | Florida |
| United States | Galderma Investigational Site (# 8528) | Santa Ana | California |
| United States | Galderma Investigational Site (# 8160) | Santa Monica | California |
| United States | Galderma Investigational Site (# 8351) | Seattle | Washington |
| United States | Galderma Investigational Site (#8189) | Snellville | Georgia |
| United States | Galderma Investigational Site (# 8523) | Tampa | Florida |
| United States | Galderma Investigational Site (# 8443) | Temecula | California |
| United States | Galderma Investigational Site (# 8226) | Warren | Michigan |
| United States | Galderma Investigational Site (# 8126) | West Palm Beach | Florida |
| United States | Galderma Investigational site (8353) | Yardley | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States, Canada, Germany, Hungary, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | From Baseline to Week 12 |
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