NCT07186413 A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
| NCT ID | NCT07186413 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Galderma R&D |
| Condition | Acne Vulgaris |
| Study Type | INTERVENTIONAL |
| Enrollment | 561 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: Participants must meet the following criteria to be included in the study: 1. Male or female Chinese participants aged 9 years or older at the screening visit. 2. A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline. 3. Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline. 4. 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). 5. 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 p