CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT02189629

Run by

Galderma R&D

People needed

453

Starts

2015-02-23

Expected to finish

2017-02-23

Last updated by the study team

2019-11-14

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Galderma Investigational Site — Mobile, Alabama, United States
• Galderma Investigational Site — Rogers, Arkansas, United States
• Galderma Investigational Site — Sacramento, California, United States
• Galderma Investigational Site — San Diego, California, United States
• Galderma Investigational Site — Miami, Florida, United States
• Galderma Investigational Site — Miramar, Florida, United States
• Galderma Investigational Site — Newnan, Georgia, United States
• Galderma Investigational Site — Louisville, Kentucky, United States
• Galderma Investigational Site — Albuquerque, New Mexico, United States
• Galderma Investigational Site — New York, New York, United States
• Galderma Investigational Site — High Point, North Carolina, United States
• Galderma Investigational Site — Beachwood, Ohio, United States
• Galderma Investigational Site — Portland, Oregon, United States
• Galderma Investigational Site — Knoxville, Tennessee, United States
• Galderma Investigational Site — Chomutov, Czechia
• Galderma Investigational site — Hradec Králové, Czechia
• Galderma Investigational Site — Olomouc, Czechia
• Galderma Investigational Site — Pardubice, Czechia
• Galderma Investigational site — Prague, Czechia
• Galderma Investigational Site — Augsburg, Germany
• Galderma Investigational Site — Berlin, Germany
• Galderma Investigational Site — Berlin, Germany
• Galderma Investigational Site — Dessau, Germany
• Galderma Investigational Site — Mahlow, Germany
• Galderma Investigational Site — Münster, Germany

Full record on ClinicalTrials.gov

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