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Clinical Performance and Safety of STYLAGE® HydroMax

NCT07153237 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Aging
  • Aesthetic

Interventions

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)

Sponsors & Collaborators

  • Quantificare SA

    collaborator UNKNOWN

  • Eurofins Dermscan Pharmascan

    collaborator INDUSTRY

  • Inferential

    collaborator INDUSTRY

  • International Clinical Trials Association

    collaborator OTHER

  • Laboratoires Vivacy

    lead INDUSTRY

Principal Investigators

  • Patricia MOREL-MANDRINO, MD · Eurofins Dermscan, Villeurbanne, FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2026-03-31
Completion
2026-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153237 on ClinicalTrials.gov