Actively Recruiting
A Multicenter, Randomized, Double-blinded, Vehicle-controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Participants With Acne Vulgaris
Led by Galderma R&D · Updated on 2025-11-21
561
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of trifarotene 50 microgram per gram cream compared to a vehicle cream in treating moderate acne vulgaris on the face and trunk in Chinese participants. This phase 3, randomized, double-blind, vehicle-controlled study aims to understand how well trifarotene works when applied once daily over 12 weeks in this population. Participants will be randomly assigned to apply either trifarotene cream or vehicle cream once daily in the evening for 12 weeks. The study includes two groups: one receiving the active trifarotene cream and the other receiving the vehicle cream, both applied topically. This treatment period is the main phase of the trial where efficacy and safety are monitored. During the study, participants will attend visits to assess acne severity and lesion counts on the face and trunk, using Investigator Global Assessment (IGA) and Physician Global Assessment (PGA) scales. Researchers will track changes in inflammatory and non-inflammatory lesions from baseline to week 12, monitor adverse events, and evaluate skin tolerability at several points. Some participants will have plasma samples collected to measure drug levels. The total participation lasts 12 weeks with monitoring throughout this period.
CONDITIONS
Brief 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.
- Have at least 20 inflammatory and 25 non-inflammatory lesions on the face.
- Moderate facial acne vulgaris (grade 3) on the Investigator Global Assessment scale.
- Have at least 20 inflammatory and 20 non-inflammatory but no more than 100 non-inflammatory lesions on the trunk reachable for self-application (optional for ages 9-11).
- Moderate acne vulgaris (grade 3) on the Physician Global Assessment scale on the trunk (optional for ages 9-11).
- Female participants of non-childbearing potential or those using approved contraception with negative pregnancy tests.
- Willing and able to comply with study procedures and time commitments.
- Understand and sign informed consent; minors must have parental consent and provide assent.
- Willing to share personal information according to local regulations.
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study or within 1 month after last treatment.
- Severe or secondary forms of acne such as acne conglobata or drug-induced acne.
- More than one nodule or any cyst on the face or trunk.
- Facial or truncal hair, pigmentation, wounds, scars, or tattoos that interfere with assessments.
- Any uncontrolled or serious medical or surgical condition that poses risk or affects results.
- Abnormal lab results deemed clinically significant.
- Allergies to study creams or previous participation in trifarotene studies.
- Participation in another clinical trial within 30 days before baseline.
- Alcohol or drug abuse within 12 months.
- Unable or unwilling to undergo blood draws.
- Recent blood loss or donation over 500 mL in past 3 months.
- Use of prohibited medications or exposure to excessive UV radiation.
- Unwillingness to avoid UV exposure or prohibited medications during study.
- Vulnerable participants unable to give consent.
- More than one participant from the same household.
- Clinical site personnel or close relatives of sponsor employees.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants apply either Trifarotene 50 mcg/g cream or Vehicle cream once daily in the evening for acne treatment.
Visits at Baseline, Weeks 1, 2, 4, 8, and 12
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
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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