CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: CD5789 (trifarotene)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02189629

RD.06.SPR.18250

Details and patient eligibility

About

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

Full description

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.

Enrollment: 453 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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453 participants in 1 patient group

CD5789 (trifarotene) cream

Experimental group

Treatment:

Drug: CD5789 (trifarotene)