CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

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.