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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
561
Trifarotene cream applied QD topically.
Vehicle cream applied QD topically.
Galderma Research & Development Site #5378
Shanghai, Jing'an District, China
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.
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in Facial Non-inflammatory Lesion Count
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in Facial Inflammatory Lesion Count
Time frame: Baseline to Week 12
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
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in Truncal Non-inflammatory Lesion Count
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in Truncal Inflammatory Lesion Count
Time frame: Baseline to Week 12
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Number of Participants With Adverse Events (AEs), Including AEs of Special Interest (AESIs), Treatment-emergent AEs (TEAEs), and Serious AEs (SAEs)
Time frame: Baseline to Week 12
Investigator's Local Tolerability Assessment
Local tolerability, which includes individual assessment of erythema, scaling, dryness, and stinging/burning, will be graded on a 4-point scale (ranging from 0 \[None\] to 3 \[Severe\]) separately for the face and trunk. A higher score indicated a severe outcome. The areas for evaluation on the face include the forehead, nose, chin, and right and left cheeks. The areas for evaluation on the upper trunk include the shoulders, right and left chest, and right and left upper back, which are accessible to self-application by the subject. If IP is applied to the middle and/or lower back, the local tolerability assessment of the trunk will include the upper, middle, and/or lower back, if applicable, and will be analyzed as 1 area.
Time frame: Baseline, Weeks 1, 2, 4, 8 and 12
Observed Plasma Concentration (Ct) in Selected Participants
Three PK samples will be collected to inform trifarotene exposure in adult participants.
Time frame: Baseline, Week 4 and Week 12