The primary objective is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris.
Male or female Chinese participants aged 9 years or older at the screening visit.
A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline.
Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline.
A minimum of 20 inflammatory lesions and 20 non-inflammatory lesions but no more than 100 non-inflammatory lesion counts on the trunk (shoulders, upper back, and upper anterior chest) reachable for self-application of investigational product by the participant at Screening and Baseline (optional criterion for participant between 9 and 11 years of age).
Pregnant women (positive serum pregnancy test result at the screening visit or positive UPT at the baseline visit), breastfeeding women, or women planning a pregnancy during the study or within 1 month after the last investigational product application.
Severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g., chloracne, drug-induced acne) at the screening and baseline visits.
More than 1 nodule on the face at the screening and baseline visits.
More than 1 nodule on the trunk at the screening and baseline visits.
Parallel
Trifarotene
DrugTrifarotene cream applied QD topically.
Vehicle Cream
DrugVehicle cream applied QD topically.
Percentage of Participants with Investigator Global Assessment (IGA) Success (Face only) at Week 12
The areas defined for IGA assessment are the forehead, each cheek, chin, and nose. IGA will be confined to a global assessment of each area defined above. IGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Success Rate, defined as the percentage of participants who achieve an IGA score (face only) of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Change from Baseline to Week 12 in Facial Non-inflammatory Lesion Count
Change from Baseline to Week 12 in Facial Inflammatory Lesion Count
Percentage of Participants with Physician Global Assessment (PGA) Success at Week 12
The areas defined for PGA assessment are shoulders, upper back and upper anterior chest which are accessible to self-application by the participants. PGA will be confined to a global assessment of each areas defined above. The PGA is a snapshot static assessment to be done prior to detailed lesion counts. PGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. PGA Success, defined as the percentage of participants who achieve a PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12
Change from Baseline to Week 12 in Truncal Non-inflammatory Lesion Count
Change from Baseline to Week 12 in Truncal Inflammatory Lesion Count
Number of Participants With Adverse Events (AEs), Including AEs of Special Interest (AESIs), Treatment-emergent AEs (TEAEs), and Serious AEs (SAEs)
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