Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
NCT ID: NCT02566369
Last Updated: 2019-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1208 participants
INTERVENTIONAL
2015-11-30
2017-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CD5789 (trifarotene) 50μg/g Cream
CD5789 (trifarotene) 50μg/g Cream
CD5789 (trifarotene) 50μg/g cream
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
Placebo Cream
Placebo cream
Placebo cream
Placebo cream applied once daily for 12 weeks
Interventions
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CD5789 (trifarotene) 50μg/g cream
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
Placebo cream
Placebo cream applied once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
9 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Jerry Tan, MD
Role: PRINCIPAL_INVESTIGATOR
Windsor Clinical Research
Ulrike Blume-Peytavi, MD
Role: PRINCIPAL_INVESTIGATOR
Charité Universitätsmedizin
Locations
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Galderma Investigational Site (8258)
Mobile, Alabama, United States
Galderma Investigational Site (# 8530)
Glendale, Arizona, United States
Galderma Investigational Site (# 8511)
Phoenix, Arizona, United States
Galderma Investigational Site (# 8009)
Hot Springs, Arkansas, United States
Galderma Investigational Site (# 8355)
Rogers, Arkansas, United States
Galderma Investigational Site (# 8456)
Beverly Hills, California, United States
Galderma Investigational site (8578)
Cerritos, California, United States
Galderma Investigational Site (# 8526)
Clovis, California, United States
Galderma Investigational Site (8577)
Encinitas, California, United States
Galderma Investigational Site (# 8224)
Fremont, California, United States
Galderma Investigational Site (# 8509)
Fullerton, California, United States
Galderma Investigational Site (# 8507)
Huntington Beach, California, United States
Galderma Investigational Site (# 8425)
Newport Beach, California, United States
Galderma Investigational Site (# 8052)
Oceanside, California, United States
Galderma Investigational Site (# 8528)
Santa Ana, California, United States
Galderma Investigational Site (# 8160)
Santa Monica, California, United States
Galderma Investigational Site (# 8443)
Temecula, California, United States
Galderma Investigational Site (8572)
Colorado Springs, Colorado, United States
Galderma Investigational Site (# 8510)
Englewood, Colorado, United States
Galderma Investigational Site (# 8370)
Boynton Beach, Florida, United States
Galderma Investigational Site (# 8543)
Fort Lauderdale, Florida, United States
Galderma Investigational Site (8143)
Miami, Florida, United States
Galderma Investigational site (8259)
Miramar, Florida, United States
Galderma Investigational Site (# 8522)
North Miami Beach, Florida, 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 (# 8529)
Sanford, Florida, United States
Galderma Investigational Site (# 8455)
St. Petersburg, Florida, United States
Galderma Investigational Site (# 8523)
Tampa, Florida, United States
Galderma Investigational Site (# 8126)
West Palm Beach, Florida, United States
Galderma Investigational Site (#8189)
Snellville, Georgia, United States
Galderma Investigational Site (8582)
Idaho Falls, Idaho, United States
Galderma Investigational Site (# 8367)
Arlington Heights, Illinois, United States
Galderma Investigational Site (8191)
Chicago, Illinois, United States
Galderma Investigational site (8571)
Darien, Illinois, United States
Galderma Investigational Site (8575)
Oakbrook Terrace, Illinois, United States
Galderma Investigational Site (# 8366)
Plainfield, Indiana, United States
Galderma Investigational Site (# 8532)
Overland Park, Kansas, United States
Galderma Investigational Site (# 8069)
Louisville, Kentucky, United States
Galderma Investigational Site (8092)
Louisville, Kentucky, United States
Galderma Investigational Site (8545)
Owensboro, Kentucky, United States
Galderma Investigational Site (8457)
Monroe, Louisiana, United States
Galderma Investigational site (8580)
New Orleans, Louisiana, United States
Galderma Investigational Site (# 8012)
Glenn Dale, Maryland, United States
Galderma Investigational Site (# 8525)
Rockville, Maryland, United States
Galderma Investigational Site (# 8541)
Quincy, Massachusetts, United States
Galderma Investigational Site (#8512)
Bay City, Michigan, United States
Galderma Investigational Site (8574)
Clarkston, Michigan, United States
Galderma Investigational Site (#8033)
Clinton Township, Michigan, United States
Galderma Investigational Site (8129)
Fort Gratiot, Michigan, United States
Galderma Investigational Site (# 8226)
Warren, Michigan, United States
Galderma Investigational Site (# 8521)
Saint Joseph, Missouri, United States
Galderma Investigational Site (#8027)
St Louis, Missouri, United States
Galderma Investigational Site (# 8544)
Lincoln, Nebraska, United States
Galderma Investigational Site (# 8108)
Las Vegas, Nevada, United States
Galderma Investigational Site (#8420)
Newington, New Hampshire, United States
Galderma Investigational Site (# 8506)
Hackensack, New Jersey, United States
Galderma Investigational Site (#8500)
Brooklyn, New York, United States
Galderma Investigational Site (8524)
East Setauket, 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 (8279)
New York, New York, United States
Galderma Investigational Site (8566)
Charlotte, North Carolina, United States
Galderma Investigational Site (#8514)
Hickory, North Carolina, United States
Galderma Investigational Site (# 8195)
Beachwood, Ohio, United States
Galderma Investigational Site (# 8016)
Cincinnati, Ohio, United States
Galderma Investigational site (8595)
Dublin, Ohio, United States
Galderma Investigational Site (8188)
Hershey, Pennsylvania, United States
Galderma Investigational site (8353)
Yardley, Pennsylvania, United States
Galderma Investigational Site (# 8369)
Charleston, South Carolina, United States
Galderma Investigational Site (# 8117)
Knoxville, Tennessee, United States
Galderma Investigational Site (# 8515)
Nashville, Tennessee, United States
Galderma Investigational Site (# 8542)
Arlington, Texas, United States
Galderma Investigational Site (#8513)
Austin, Texas, United States
Galderma Investigational site (8579)
Beaumont, Texas, United States
Galderma Investigational Site (# 8245)
Dallas, Texas, United States
Galderma Investigational Site (8183)
Houston, Texas, United States
Galderma Investigational site (8576)
Katy, Texas, United States
Galderma Investigational Site (8583)
Murphy, Texas, United States
Galderma Investigational Site (8567)
San Antonio, Texas, United States
Galderma Investigational site (8433)
San Antonio, Texas, United States
Galderma Investigational site (8329)
San Antonio, Texas, United States
Galderma Investigational site (8106)
Layton, Utah, United States
Galderma Investigational Site (# 8214)
Salt Lake City, Utah, United States
Galderma Investigational Site (# 8351)
Seattle, Washington, United States
Galderma Investigational Site (# 8215)
Calgary, Alberta, Canada
Galderma Investigational site (8161)
Surrey, British Columbia, Canada
Galderma Investigational Site (# 8154)
Winnipeg, Manitoba, Canada
Galderma Investigational Site (8586)
Barrie, Ontario, 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 (8001)
Waterloo, Ontario, Canada
Galderma Investigational Site (# 8060)
Windsor, Ontario, Canada
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, , Germany
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, , Hungary
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, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.06.SPR.18251
Identifier Type: -
Identifier Source: org_study_id
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