Actively Recruiting
A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
Led by Galderma R&D · Updated on 2025-11-21
561
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female Chinese participants aged 9 years or older at screening.
- At least 20 inflammatory lesions and 25 non-inflammatory lesions on the face at screening and baseline.
- Moderate facial acne vulgaris severity (grade 3) on the Investigator Global Assessment scale at screening and baseline.
- At least 20 inflammatory lesions and 20 to 100 non-inflammatory lesions on the trunk reachable for self-application, at screening and baseline (optional for ages 9 to 11).
- Moderate acne severity (grade 3) on the Physician's Global Assessment scale on the trunk reachable for self-application, at screening and baseline (optional for ages 9 to 11).
- Female participants of non-childbearing potential (premenstrual or postmenopausal) meeting specific criteria.
- Female participants of childbearing potential must have negative pregnancy tests and use approved contraception during the study and for 1 month after last dose.
- Premenstrual participants starting menses during the study must use approved contraception during the study and 1 month after last dose.
- Willing and able to comply with all study time commitments and procedures.
- Understands and signs informed consent at screening before any study procedures.
- Participants under 18 must have parent/legal representative willing to comply and sign consent; participant must sign assent.
- At selected sites, agreement to participate in study photographs with appropriate consent.
- Willing to share personal information according to local privacy regulations.
You will not qualify if you...
- Pregnant or breastfeeding women, or women planning pregnancy during study or within 1 month after last dose.
- Severe or secondary forms of acne at screening and baseline.
- More than 1 nodule on face or trunk at screening and baseline.
- Any acne cyst on face or trunk at screening and baseline.
- Facial or truncal hair, abnormal pigmentation, wounds, scars, or tattoos interfering with assessments.
- Uncontrolled or serious medical or surgical conditions that may interfere with results or pose risk.
- Significant abnormal laboratory test results at screening.
- Known allergies or hypersensitivity to study cream components.
- Previous participation in any trifarotene cream clinical study.
- Current or recent participation (within 30 days) in other drug or device trials.
- Alcohol or drug abuse within 12 months before screening.
- Inability or unwillingness to undergo multiple blood draws.
- Significant recent blood loss or donation.
- Use of prohibited medications or treatments during study.
- Recent or unwillingness to avoid excessive ultraviolet radiation exposure.
- Use of drugs that may interfere with acne assessment or worsen acne.
- Participant vulnerability or inability to consent.
- More than 1 participant from the same household.
- Clinical site personnel or close relatives or employees of the sponsor company.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Galderma Research & Development Site #5378
Shanghai, Jing'an District, China
Actively Recruiting
Research Team
G
Galderma Research & Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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