Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face

Summary

The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Conditions

• Volume Deficiency in the Mid-Face
• Aging
• Aesthetics

Interventions

DEVICE

STYLAGE® XXL

Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face. Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face. Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.

DEVICE

STYLAGE® XXL

Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face. Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face. Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.

Sponsors & Collaborators

• Avania B.V.

  collaborator UNKNOWN

• Canfield Scientific Inc.

  collaborator UNKNOWN

• Laboratoires Vivacy

  lead INDUSTRY

Principal Investigators

• Hervé RASPALDO, MD · Private Clinic, GENEVA, SWITZERLAND

• Hugues CARTIER, MD · Centre Medical Saint-Jean, ARRAS, FRANCE

• Thomas RAPPL, MD · Medical Aesthetic Research Academy, GRAZ, AUSTRIA

• Cyril CLERICO, MD · Private Practice, NICE, FRANCE

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-06

Primary Completion

2024-05-15

Completion

2025-04-25

Countries

• France

Study Locations