A Multicenter, Randomized, Double-blinded, Parallel-group, Vehicle-controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
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.
∙ Participants must meet the following criteria to be included in the study:
• 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).
• Acne vulgaris severity grade 3 (moderate) on the PGA scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of investigational product by the participant (optional criterion for participants between 9 and 11 years of age).
• Female participants of non-childbearing potential, i.e., premenstrual, or postmenopausal. Postmenopausal participants must meet one criterion at Screening:
‣ Absence of menstrual bleeding for 1 year before screening with no other medical reason, confirmed with follicle-stimulating hormone level in the postmenopausal range.
⁃ Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before Screening.
• Female participants of childbearing potential (i.e., fertile, after menarche and until becoming postmenopausal unless permanently sterile) must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test (UPT) at the baseline visit (with a sensitivity of 25 international units per litre \[IU/L\] or less). They must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product.
• Premenstrual participants who start menses during the study must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product.
• Willing and able to comply with all the time commitments and procedural requirements of the clinical study protocol.
⁃ Understands and signs an informed consent form (ICF) at the screening visit, before any investigational procedures are performed.
⁃ Participants who are younger than 18 years of age and whose parent/legal representative is willing/able to comply with the study requirements and understand/sign the ICF at the screening visit, before any investigational procedures are performed, will sign the assent ICF at the screening visit.
⁃ At selected clinical sites: If a participant who is 18 years of age or older at the screening visit and agrees to participate in study photographs, verified by dating and signing a separate approved photography ICF. For participants younger than 18 years of age, an assent photography ICF signed by the participant in conjunction with a photography ICF signed by the parents(s)/legal representative at the screening visit.
⁃ Participant is informed of terms pertaining to personal information protection and privacy and is willing to share personal information and data, in accordance with local regulations.