Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris

Phase 3

Completed

Conditions: Acne Vulgaris

Interventions: Drug: CD5789 (trifarotene) 50μg/g cream
Drug: Placebo cream

Registration Number: NCT02566369

Lead Sponsor: Galderma R&D

Brief Summary: Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1208

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD5789 (trifarotene) 50μg/g Cream	CD5789 (trifarotene) 50μg/g cream	CD5789 (trifarotene) 50μg/g Cream
Placebo Cream	Placebo cream	Placebo cream

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) Success Rate at Week 12	From Baseline to 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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (124): Galderma Investigational Site (5254)
🇭🇺
Nyíregyháza, Hungary
Galderma Investigational Site (8594)
🇵🇷
Caguas, Puerto Rico
Galderma Investigational Site (8143)
🇺🇸
Miami, Florida, United States
Galderma Investigational Site (# 8108)
🇺🇸
Las Vegas, Nevada, United States
Galderma Investigational Site (# 8016)
🇺🇸
Cincinnati, Ohio, United States
Galderma Investigational Site (# 8370)
🇺🇸
Boynton Beach, Florida, United States
Galderma Investigational Site (# 8455)
🇺🇸
Saint Petersburg, Florida, United States
Galderma Investigational Site (#8189)
🇺🇸
Snellville, Georgia, United States
Galderma Investigational Site (# 8367)
🇺🇸
Arlington Heights, Illinois, United States
Galderma Investigational Site (#8213)
🇺🇸
Ormond Beach, Florida, 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 (8545)
🇺🇸
Owensboro, Kentucky, United States
Galderma Investigational Site (# 8521)
🇺🇸
Saint Joseph, Missouri, United States
Galderma Investigational Site (8574)
🇺🇸
Clarkston, Michigan, United States
Galderma Investigational Site (8188)
🇺🇸
Hershey, Pennsylvania, United States
Galderma Investigational Site (#8500)
🇺🇸
Brooklyn, New York, United States
Galderma Investigational Site (# 8506)
🇺🇸
Hackensack, New Jersey, United States
Galderma Investigational Site (# 8226)
🇺🇸
Warren, Michigan, United States
Galderma Investigational Site (#8420)
🇺🇸
Newington, New Hampshire, United States
Galderma Investigational Site (#8027)
🇺🇸
Saint Louis, Missouri, United States
Galderma Investigational Site (# 8542)
🇺🇸
Arlington, Texas, United States
Galderma Investigational Site (# 8195)
🇺🇸
Beachwood, Ohio, United States
Galderma Investigational Site (8568)
🇺🇸
New York, New York, United States
Galderma Investigational Site (#8514)
🇺🇸
Hickory, North Carolina, United States
Galderma Investigational Site (8279)
🇺🇸
New York, New York, United States
Galderma Investigational site (8576)
🇺🇸
Katy, Texas, United States
Galderma Investigational site (8106)
🇺🇸
Layton, Utah, United States
Galderma Investigational Site (8183)
🇺🇸
Houston, Texas, United States
Galderma Investigational Site (5604)
🇩🇪
Berlin, Germany
Galderma Investigational Site (5802)
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Balatonfüred, Hungary
Galderma Investigational Site (5812)
🇭🇺
Budapest, Hungary
Galderma Investigational site (8161)
🇨🇦
Surrey, British Columbia, Canada
Galderma Investigational Site (8586)
🇨🇦
Barrie, Ontario, Canada
Galderma Investigational Site (5685)
🇭🇺
Cegléd, Hungary
Galderma Investigational site (8100)
🇵🇷
Carolina, Puerto Rico
Galderma Investigational Site (8593)
🇵🇷
San Juan, Puerto Rico
Galderma Investigational Site (5572)
🇩🇪
Dessau, Germany
Galderma Investigational Site (5434)
🇩🇪
Dresden, Germany
Galderma Investigational Site (5204)
🇩🇪
Dresden, Germany
Galderma Investigational Site (5543)
🇩🇪
Mainz, Germany
Galderma Investigational Site (# 8511)
🇺🇸
Phoenix, Arizona, United States
Galderma Investigational Site (8567)
🇺🇸
San Antonio, Texas, United States
Galderma Investigational site (8329)
🇺🇸
San Antonio, Texas, United States
Galderma Investigational Site (# 8214)
🇺🇸
Salt Lake City, Utah, United States
Galderma Investigational Site (5566)
🇩🇪
Augsburg, Germany
Galderma Investigational Site (8258)
🇺🇸
Mobile, Alabama, United States
Galderma Investigational Site (# 8355)
🇺🇸
Rogers, Arkansas, United States
Galderma Investigational Site (# 8526)
🇺🇸
Clovis, California, United States
Galderma Investigational Site (8577)
🇺🇸
Encinitas, California, United States
Galderma Investigational Site (# 8509)
🇺🇸
Fullerton, California, United States
Galderma Investigational Site (# 8507)
🇺🇸
Huntington Beach, California, United States
Galderma Investigational Site (# 8052)
🇺🇸
Oceanside, California, United States
Galderma Investigational Site (# 8528)
🇺🇸
Santa Ana, California, United States
Galderma Investigational Site (# 8510)
🇺🇸
Englewood, Colorado, United States
Galderma Investigational Site (# 8543)
🇺🇸
Fort Lauderdale, Florida, United States
Galderma Investigational Site (# 8522)
🇺🇸
North Miami Beach, Florida, United States
Galderma Investigational Site (# 8523)
🇺🇸
Tampa, Florida, United States
Galderma Investigational Site (# 8529)
🇺🇸
Sanford, Florida, United States
Galderma Investigational Site (# 8126)
🇺🇸
West Palm Beach, Florida, United States
Galderma Investigational Site (8582)
🇺🇸
Idaho Falls, Idaho, United States
Galderma Investigational Site (8191)
🇺🇸
Chicago, Illinois, United States
Galderma Investigational Site (# 8532)
🇺🇸
Overland Park, Kansas, United States
Galderma Investigational Site (#8512)
🇺🇸
Bay City, Michigan, United States
Galderma Investigational Site (# 8012)
🇺🇸
Glenn Dale, Maryland, United States
Galderma Investigational Site (# 8541)
🇺🇸
Quincy, Massachusetts, United States
Galderma Investigational Site (8457)
🇺🇸
Monroe, Louisiana, United States
Galderma Investigational Site (# 8525)
🇺🇸
Rockville, Maryland, United States
Galderma Investigational Site (#8033)
🇺🇸
Clinton Township, Michigan, United States
Galderma Investigational Site (8129)
🇺🇸
Fort Gratiot, Michigan, United States
Galderma Investigational Site (8524)
🇺🇸
East Setauket, New York, United States
Galderma Investigational Site (# 8544)
🇺🇸
Lincoln, Nebraska, United States
Galderma Investigational Site (8585)
🇺🇸
New York, New York, United States
Galderma Investigational Site (8566)
🇺🇸
Charlotte, North Carolina, United States
Galderma Investigational site (8595)
🇺🇸
Dublin, Ohio, United States
Galderma Investigational site (8353)
🇺🇸
Yardley, Pennsylvania, United States
Galderma Investigational Site (# 8117)
🇺🇸
Knoxville, Tennessee, United States
Galderma Investigational Site (8583)
🇺🇸
Murphy, Texas, United States
Galderma Investigational Site (# 8245)
🇺🇸
Dallas, Texas, United States
Galderma Investigational Site (# 8215)
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Calgary, Alberta, Canada
Galderma Investigational Site (# 8154)
🇨🇦
Winnipeg, Manitoba, Canada
Galderma Investigational Site (# 8135)
🇨🇦
North Bay, Ontario, Canada
Galderma Investigational Site (# 8426)
🇨🇦
London, Ontario, Canada
Galderma Investigational Site (# 8168)
🇨🇦
Oakville, Ontario, Canada
Galderma Investigational Site (8001)
🇨🇦
Waterloo, Ontario, Canada
Galderma Investigational Site (# 8338)
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Richmond Hill, Ontario, Canada
Galderma Investigational Site (# 8060)
🇨🇦
Windsor, Ontario, Canada
Galderma Investigational Site (5815)
🇩🇪
Berlin, Germany
Galderma Investigational Site (5750)
🇩🇪
Darmstadt, Germany
Galderma Investigational Site (5146)
🇩🇪
Eberstadt, Germany
Galderma Investigational Site (5635)
🇩🇪
Langenau, Germany
Galderma Investigational Site (5307)
🇩🇪
Münster, Germany
Galderma Investigational Site (5567)
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Budapest, Hungary
Galderma Investigational Site (5263)
🇭🇺
Püspökladány, Hungary
Galderma Investigational Site (5767)
🇭🇺
Szekszàrd, Hungary
Galderma Investigational Site (5811)
🇭🇺
Pécel, Hungary
Galderma Investigational Site (5237)
🇭🇺
Szeged, Hungary
Galderma Investigational Site (8592)
🇵🇷
Aibonito, Puerto Rico
Galderma Investigational Site (# 8351)
🇺🇸
Seattle, Washington, United States
Galderma Investigational Site (# 8340)
🇨🇦
Peterborough, Ontario, Canada
Galderma Investigational Site (8572)
🇺🇸
Colorado Springs, Colorado, United States
Galderma Investigational Site (# 8530)
🇺🇸
Glendale, Arizona, United States
Galderma Investigational Site (# 8531)
🇺🇸
Orange Park, Florida, United States
Galderma Investigational site (8579)
🇺🇸
Beaumont, Texas, United States
Galderma Investigational Site (# 8038)
🇨🇦
Hamilton, Ontario, Canada
Galderma Investigational Site (# 8026)
🇨🇦
Markham, Ontario, Canada
Galderma Investigational Site (# 8515)
🇺🇸
Nashville, Tennessee, United States
Galderma Investigational site (8433)
🇺🇸
San Antonio, Texas, United States
Galderma Investigational Site (# 8443)
🇺🇸
Temecula, California, United States
Galderma Investigational Site (# 8009)
🇺🇸
Hot Springs, Arkansas, United States
Galderma Investigational Site (# 8224)
🇺🇸
Fremont, California, United States
Galderma Investigational Site (5838)
🇩🇪
Hamburg, Germany
Galderma Investigational Site (# 8160)
🇺🇸
Santa Monica, California, United States
Galderma Investigational Site (# 8425)
🇺🇸
Newport Beach, California, United States
Galderma Investigational site (8259)
🇺🇸
Miramar, Florida, United States
Galderma Investigational site (8578)
🇺🇸
Cerritos, California, United States
Galderma Investigational Site (# 8456)
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Beverly Hills, California, United States
Galderma Investigational Site (8502)
🇺🇸
Orlando, Florida, United States
Galderma Investigational site (8580)
🇺🇸
New Orleans, Louisiana, United States
Galderma Investigational Site (# 8069)
🇺🇸
Louisville, Kentucky, United States
Galderma Investigational Site (8092)
🇺🇸
Louisville, Kentucky, United States
Galderma Investigational Site (# 8369)
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Charleston, South Carolina, United States
Galderma Investigational Site (#8513)
🇺🇸
Austin, Texas, United States