CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

• Status: Completed
• Trial end date: 2017-02-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Trifarotene

Criteria

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.