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A Prospective, Multicentric, Randomized, Evaluator-blind, Controlled, Interventional Clinical Investigation Evaluating the Clinical Performance and Safety of STYLAGE® HydroMax, a Hyaluronic Acid-based Gel (FHAME)
FHAME is a post-market clinical investigation designed to strengthen the clinical evidence supporting the effectiveness of STYLAGE® HydroMax in the treatment of superficial wrinkles, primarily on the cheeks.
Details
| Lead sponsor | Laboratoires Vivacy |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 81 |
| Start date | 2025-09-09 |
| Completion | 2026-11 |
Conditions
- Aging
- Aesthetic
Interventions
- STYLAGE® HydroMax
Primary outcomes
- Mean changes in cheek wrinkle score (independant blinded evaluator) — 6 weeks port-baseline
Mean change from baseline in cheek wrinkle severity score assessed by an independent blinded evaluator at 6 weeks (V3a/V3b) post-baseline using the 8-grade Bazin cheek wrinkle scale (0 = no wrinkles, 8 = most severe wrinkles) during live assessments.
Countries
France