CD5789 (Trifarotene) Long Term Safety Study on 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:February 23, 2015
End Date:February 23, 2017

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A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS

Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of
treatment on the face and trunk for acne vulgaris.

To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term
treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a
secondary objective.

Inclusion Criteria:

- The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening
and Baseline visits.

- The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions
at Screening and Baseline visits on the face.

- Exclusion Criteria:

- The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary
acne form (chloracne, drug-induced acne, etc.).

- The Subject has more than 1 nodule on the face at Screening and at Baseline visits.

- The Subject has any acne cyst on the face at Screening and at Baseline visits.
We found this trial at
15
sites
Rogers, Arkansas 72758
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Rogers, AR
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Albuquerque, New Mexico
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Albuquerque, NM
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Beachwood, Ohio 44122
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Beachwood, OH
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Chomutov,
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High Point, North Carolina 27262
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High Point, NC
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Knoxville, Tennessee
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Knoxville, TN
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Louisville, Kentucky 40202
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Louisville, KY
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Miami, FL
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Miramar, FL
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Mobile, Alabama 36608
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Mobile, AL
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New York, New York 10022
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New York, NY
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Newnan, Georgia 30277
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Newnan, GA
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Portland, Oregon 97210
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from
Portland, OR
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Sacramento, California
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Sacramento, CA
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San Diego, California 92123
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from
San Diego, CA
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