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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - Any
Updated:7/12/2018
Start Date:November 30, 2015
End Date:November 14, 2017

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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.

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.

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
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82
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Clarkston, Michigan 48346
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Arlington, Texas 76011
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Arlington Heights, Illinois 60005
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Bay City, Michigan 48706
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Beachwood, Ohio 44122
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Beaumont, Texas 77701
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Beverly Hills, California 90212
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Boynton Beach, Florida 33437
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Brooklyn, New York 11203
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Calgary,
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Cerritos, California 90703
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Charleston, South Carolina 29414
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Charlotte, North Carolina 28277
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Chicago, Illinois
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Clinton Township, Michigan 48038
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Clovis, California 93612
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Colorado Springs, Colorado 80920
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Dallas, Texas 75230
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Darien, Illinois 60561
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East Setauket, New York 11733
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Encinitas, California 92024
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Englewood, Colorado 80113
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Fort Gratiot, Michigan 48059
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Fort Lauderdale, Florida 33316
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Fremont, California 94538
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Fullerton, California 92835
Phone: 817-961-5406
1959
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Glendale, Arizona 85308
1663
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Glenn Dale, Maryland 20769
337
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Hackensack, New Jersey 07601
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337
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Hot Springs, Arkansas
667
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Huntington Beach, California 92647
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Idaho Falls, Idaho 83404
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Monroe, Louisiana 71203
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New Orleans, Louisiana 70130
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Newington, New Hampshire 03801
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Newport Beach, California 92663
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Oakbrook Terrace, Illinois 60180
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1945
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Orange Park, Florida 32073
Phone: 817-961-5406
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Orlando, Florida 32814
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Rockville, Maryland 20850
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Rogers, Arkansas 72758
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1986
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