Double-Blind 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:7/19/2018
Start Date:November 2015
End Date:May 12, 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.


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
We found this trial at
30
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Wilmington, North Carolina 28401
2275
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Wilmington, NC
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Ann Arbor, Michigan 48103
1931
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Austin, Texas 78759
1212
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Aventura, Florida 33180
2320
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Aventura, FL
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Beverly, Massachusetts 01915
2586
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Beverly, MA
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Birmingham, Alabama
1785
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Birmingham, AL
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Brooklyn, New York 11203
2436
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Brooklyn, NY
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1970
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Chomutov,
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Corbin, Kentucky 40701
1907
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Corbin, KY
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Dallas, Texas 75230
1223
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Dallas, TX
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Detroit, Michigan
1966
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Detroit, MI
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Fort Smith, Arkansas 72916
1340
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Fort Smith, AR
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Fort Washington, Pennsylvania 19034
2373
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Fort Washington, PA
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Goodlettsville, Tennessee
1766
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Goodlettsville, TN
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Greer, South Carolina 29650
2025
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Greer, SC
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Houston, Texas 77004
1358
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Houston, TX
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Los Angeles, California
13
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Los Angeles, CA
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2319
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Miami, FL
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Miami Lakes, Florida 33016
2311
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Miami Lakes, FL
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Murrieta, California 92562
58
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Murrieta, CA
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Pflugerville, Texas 78660
1215
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Pflugerville, TX
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Philadelphia, Pennsylvania 19103
2374
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Philadelphia, PA
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Phoenix, Arizona 85032
343
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San Antonio, Texas
1188
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Santa Ana, California 92705
24
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Santa Ana, CA
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Stony Brook, New York
2182
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Stony Brook, NY
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Tucson, Arizona 85712
429
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Tucson, AZ
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Walla Walla, Washington 99362
828
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Walla Walla, WA
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Webster, Texas 77598
1377
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Webster, TX
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West Palm Beach, Florida 33406
2304
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West Palm Beach, FL
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