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Study of a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face (FaceHyal)

NCT05747456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-09-10

No results posted yet for this study

Summary

The primary objective of the study is to demonstrate the superiority of IPN-21-SENSE 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

IPN-21-SENSE

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.

DEVICE

IPN-21-SENSE

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.

Sponsors & Collaborators

  • Laboratoires Vivacy

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2024-04-30
Completion
2025-09-02

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 NCT05747456 on ClinicalTrials.gov