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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Healthy Volunteers: f
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∙ 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.

Locations
Other Locations
China
Galderma Research & Development Site #5378
RECRUITING
Shanghai
Contact Information
Primary
Galderma Research & Development
Clinical.Studies@galderma.com
817-961-5000
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 561
Treatments
Experimental: Trifarotene Cream
Participants will apply Trifarotene 50 mcg/g cream once daily (QD) in the evening for 12 weeks.
Active_comparator: Vehicle Cream
Participants will apply Vehicle cream QD in the evening for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Galderma R&D

This content was sourced from clinicaltrials.gov

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