NCT07153237

Clinical Performance and Safety of STYLAGE® HydroMax

A Prospective, Multicentric, Randomized, Evaluator-blind, Controlled, Interventional Clinical Investigation Evaluating the Clinical Performance and Safety of STYLAGE® HydroMax, a Hyaluronic Acid-based Gel

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Laboratoires Vivacy · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

FHAME is an interventional, post-market, multicentric, prospective, randomized clinical investigation conducted in subjects without any pathology, treated with CE-marked STYLAGE® HydroMax to confirm and update its clinical performance and safety. The primary objective of the study is to assess the mean change from baseline in cheek wrinkle severity, evaluated by an independent blinded assessor at six weeks post-baseline using the Bazin cheek wrinkle scale during live assessments. Clinical performance will be demonstrated if the mean change in the Bazin cheek wrinkle score at six weeks post-baseline is statistically superior in the treatment group (Group A) compared to the control group (Group B). To demonstrate the superiority of STYLAGE® HydroMax compared to no treatment, a total of 81 subjects will be randomized in the study. The overall duration of the study is expected to be approximately seventeen months, including a recruitment period of around six months, a screening period of two weeks, and an investigation period of thirty-six weeks post-randomization for Group A and forty-two weeks for Group B.

Conditions

• Aging
• Aesthetic

Interventions

Type	Name	Description
DEVICE	STYLAGE® HydroMax	3 injection sessions : Group A: at week 0 (V1a), week 3 (V2a), and week 24 (V5a). Group B: at week 6 (V3b), week 3 from V3b (V4b), and week 24 from V3b (V7b)

Timeline

• Start date: 2025-09-09
• Primary completion: 2026-03-01
• Completion: 2026-11-01
• First posted: 2025-09-03
• Last updated: 2025-09-10

Locations

2 sites across 1 country: France