- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02566369
Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
October 28, 2019 updated by: Galderma R&D
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
Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
1208
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T3A 2N1
- Galderma Investigational Site (# 8215)
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- Galderma Investigational site (8161)
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
- Galderma Investigational Site (# 8154)
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Galderma Investigational Site (8586)
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Hamilton, Ontario, Canada, L8N 1V6
- Galderma Investigational Site (# 8038)
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London, Ontario, Canada, N5X 2P1
- Galderma Investigational Site (# 8426)
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Markham, Ontario, Canada, L3P 1X2
- Galderma Investigational Site (# 8026)
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North Bay, Ontario, Canada, P1B 3Z7
- Galderma Investigational Site (# 8135)
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Oakville, Ontario, Canada, L6J 7W5
- Galderma Investigational Site (# 8168)
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Peterborough, Ontario, Canada, K9J 5K2
- Galderma Investigational Site (# 8340)
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Richmond Hill, Ontario, Canada, L4B 1A5
- Galderma Investigational Site (# 8338)
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Waterloo, Ontario, Canada, N2J 1C4
- Galderma Investigational Site (8001)
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Windsor, Ontario, Canada, N8W 5L7
- Galderma Investigational Site (# 8060)
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Augsburg, Germany, 86179
- Galderma Investigational Site (5566)
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Berlin, Germany, 10117
- Galderma Investigational Site (5604)
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Berlin, Germany, 13507
- Galderma Investigational Site (5815)
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Darmstadt, Germany, 64283
- Galderma Investigational Site (5750)
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Dessau, Germany, 6847
- Galderma Investigational Site (5572)
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Dresden, Germany, 1097
- Galderma Investigational Site (5204)
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Dresden, Germany, 1307
- Galderma Investigational Site (5434)
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Eberstadt, Germany, 64297
- Galderma Investigational Site (5146)
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Hamburg, Germany, 20354
- Galderma Investigational Site (5838)
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Langenau, Germany, 89129
- Galderma Investigational Site (5635)
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Mainz, Germany, 55131
- Galderma Investigational Site (5543)
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Münster, Germany, 48149
- Galderma Investigational Site (5307)
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Balatonfüred, Hungary, 08230
- Galderma Investigational Site (5802)
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Budapest, Hungary, 01036
- Galderma Investigational Site (5567)
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Budapest, Hungary, 01125
- Galderma Investigational Site (5812)
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Cegléd, Hungary, 02700
- Galderma Investigational Site (5685)
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Nyíregyháza, Hungary, 4400
- Galderma Investigational Site (5254)
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Pécel, Hungary, 02119
- Galderma Investigational Site (5811)
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Püspökladány, Hungary, 4150
- Galderma Investigational Site (5263)
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Szeged, Hungary, 6720
- Galderma Investigational Site (5237)
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Szekszàrd, Hungary, 07100
- Galderma Investigational Site (5767)
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Aibonito, Puerto Rico, 705
- Galderma Investigational Site (8592)
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Caguas, Puerto Rico, 727
- Galderma Investigational Site (8594)
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Carolina, Puerto Rico, 985
- Galderma Investigational site (8100)
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San Juan, Puerto Rico, 00909-3004
- Galderma Investigational Site (8593)
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Alabama
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Mobile, Alabama, United States, 36608
- Galderma Investigational Site (8258)
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Arizona
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Glendale, Arizona, United States, 85308
- Galderma Investigational Site (# 8530)
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Phoenix, Arizona, United States, 85018
- Galderma Investigational Site (# 8511)
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Galderma Investigational Site (# 8009)
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Rogers, Arkansas, United States, 72758
- Galderma Investigational Site (# 8355)
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California
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Beverly Hills, California, United States, 90212
- Galderma Investigational Site (# 8456)
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Cerritos, California, United States, 90703
- Galderma Investigational site (8578)
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Clovis, California, United States, 93612
- Galderma Investigational Site (# 8526)
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Encinitas, California, United States, 92024
- Galderma Investigational Site (8577)
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Fremont, California, United States, 94538
- Galderma Investigational Site (# 8224)
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Fullerton, California, United States, 92835
- Galderma Investigational Site (# 8509)
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Huntington Beach, California, United States, 92647
- Galderma Investigational Site (# 8507)
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Newport Beach, California, United States, 92663
- Galderma Investigational Site (# 8425)
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Oceanside, California, United States, 92056
- Galderma Investigational Site (# 8052)
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Santa Ana, California, United States, 92701
- Galderma Investigational Site (# 8528)
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Santa Monica, California, United States, 91301
- Galderma Investigational Site (# 8160)
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Temecula, California, United States, 92592
- Galderma Investigational Site (# 8443)
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Colorado
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Colorado Springs, Colorado, United States, 80920
- Galderma Investigational Site (8572)
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Englewood, Colorado, United States, 80113
- Galderma Investigational Site (# 8510)
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Florida
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Boynton Beach, Florida, United States, 33437
- Galderma Investigational Site (# 8370)
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Fort Lauderdale, Florida, United States, 33316
- Galderma Investigational Site (# 8543)
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Miami, Florida, United States, 33175
- Galderma Investigational Site (8143)
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Miramar, Florida, United States, 33027
- Galderma Investigational site (8259)
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North Miami Beach, Florida, United States, 33162
- Galderma Investigational Site (# 8522)
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Orange Park, Florida, United States, 32073
- Galderma Investigational Site (# 8531)
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Orlando, Florida, United States, 32814
- Galderma Investigational Site (8502)
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Ormond Beach, Florida, United States, 32174
- Galderma Investigational Site (#8213)
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Saint Petersburg, Florida, United States, 33708
- Galderma Investigational Site (# 8455)
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Sanford, Florida, United States, 32771
- Galderma Investigational Site (# 8529)
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Tampa, Florida, United States, 33609
- Galderma Investigational Site (# 8523)
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West Palm Beach, Florida, United States, 33401
- Galderma Investigational Site (# 8126)
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Georgia
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Snellville, Georgia, United States, 30078
- Galderma Investigational Site (#8189)
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Galderma Investigational Site (8582)
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Galderma Investigational Site (# 8367)
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Chicago, Illinois, United States, 60611
- Galderma Investigational Site (8191)
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Darien, Illinois, United States, 60561
- Galderma Investigational site (8571)
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Oakbrook Terrace, Illinois, United States, 60180
- Galderma Investigational Site (8575)
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Indiana
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Plainfield, Indiana, United States, 46168
- Galderma Investigational Site (# 8366)
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Kansas
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Overland Park, Kansas, United States, 66215
- Galderma Investigational Site (# 8532)
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Kentucky
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Louisville, Kentucky, United States, 40202
- Galderma Investigational Site (# 8069)
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Louisville, Kentucky, United States, 40217
- Galderma Investigational Site (8092)
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Owensboro, Kentucky, United States, 42301
- Galderma Investigational Site (8545)
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Louisiana
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Monroe, Louisiana, United States, 71203
- Galderma Investigational Site (8457)
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New Orleans, Louisiana, United States, 70130
- Galderma Investigational site (8580)
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Maryland
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Glenn Dale, Maryland, United States, 20769
- Galderma Investigational Site (# 8012)
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Rockville, Maryland, United States, 20850
- Galderma Investigational Site (# 8525)
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Massachusetts
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Quincy, Massachusetts, United States, 02169
- Galderma Investigational Site (# 8541)
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Michigan
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Bay City, Michigan, United States, 48706
- Galderma Investigational Site (#8512)
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Clarkston, Michigan, United States, 48346
- Galderma Investigational Site (8574)
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Clinton Township, Michigan, United States, 48038
- Galderma Investigational Site (#8033)
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Fort Gratiot, Michigan, United States, 48059
- Galderma Investigational Site (8129)
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Warren, Michigan, United States, 48088
- Galderma Investigational Site (# 8226)
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Missouri
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Saint Joseph, Missouri, United States, 64506
- Galderma Investigational Site (# 8521)
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Saint Louis, Missouri, United States, 63141
- Galderma Investigational Site (#8027)
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Nebraska
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Lincoln, Nebraska, United States, 68502
- Galderma Investigational Site (# 8544)
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Nevada
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Las Vegas, Nevada, United States, 89144
- Galderma Investigational Site (# 8108)
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New Hampshire
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Newington, New Hampshire, United States, 03801
- Galderma Investigational Site (#8420)
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Galderma Investigational Site (# 8506)
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New York
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Brooklyn, New York, United States, 11203
- Galderma Investigational Site (#8500)
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East Setauket, New York, United States, 11733
- Galderma Investigational Site (8524)
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New York, New York, United States, 10022
- Galderma Investigational Site (8568)
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New York, New York, United States, 10028
- Galderma Investigational Site (8585)
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New York, New York, United States, 10075
- Galderma Investigational Site (8279)
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North Carolina
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Charlotte, North Carolina, United States, 28277
- Galderma Investigational Site (8566)
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Hickory, North Carolina, United States, 28602
- Galderma Investigational Site (#8514)
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Ohio
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Beachwood, Ohio, United States, 44122
- Galderma Investigational Site (# 8195)
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Cincinnati, Ohio, United States, 45255
- Galderma Investigational Site (# 8016)
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Dublin, Ohio, United States, 43016
- Galderma Investigational site (8595)
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Galderma Investigational Site (8188)
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Yardley, Pennsylvania, United States, 19067
- Galderma Investigational site (8353)
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South Carolina
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Charleston, South Carolina, United States, 29414
- Galderma Investigational Site (# 8369)
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Tennessee
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Knoxville, Tennessee, United States, 37917
- Galderma Investigational Site (# 8117)
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Nashville, Tennessee, United States, 37203
- Galderma Investigational Site (# 8515)
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Texas
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Arlington, Texas, United States, 76017
- Galderma Investigational Site (# 8542)
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Austin, Texas, United States, 78705
- Galderma Investigational Site (#8513)
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Beaumont, Texas, United States, 77701
- Galderma Investigational site (8579)
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Dallas, Texas, United States, 75231
- Galderma Investigational Site (# 8245)
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Houston, Texas, United States, 77030
- Galderma Investigational Site (8183)
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Katy, Texas, United States, 77949
- Galderma Investigational site (8576)
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Murphy, Texas, United States, 75094
- Galderma Investigational Site (8583)
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San Antonio, Texas, United States, 78213
- Galderma Investigational Site (8567)
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San Antonio, Texas, United States, 78218
- Galderma Investigational site (8433)
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San Antonio, Texas, United States, 78229
- Galderma Investigational site (8329)
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Utah
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Layton, Utah, United States, 84041
- Galderma Investigational site (8106)
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Salt Lake City, Utah, United States, 84117
- Galderma Investigational Site (# 8214)
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Washington
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Seattle, Washington, United States, 98104
- Galderma Investigational Site (# 8351)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CD5789 (trifarotene) 50μg/g Cream
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CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
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Placebo Comparator: Placebo Cream
Placebo cream
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Placebo cream applied once daily for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigator Global Assessment (IGA) Success Rate at Week 12
Time Frame: From Baseline to Week 12
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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.
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From Baseline to Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jerry Tan, MD, Windsor Clinical Research
- Principal Investigator: Ulrike Blume-Peytavi, MD, Charité Universitätsmedizin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2015
Primary Completion (Actual)
November 14, 2017
Study Completion (Actual)
November 14, 2017
Study Registration Dates
First Submitted
October 1, 2015
First Submitted That Met QC Criteria
October 1, 2015
First Posted (Estimate)
October 2, 2015
Study Record Updates
Last Update Posted (Actual)
November 12, 2019
Last Update Submitted That Met QC Criteria
October 28, 2019
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD.06.SPR.18251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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