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

Aging Clinical Trial

Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study of IPN-21-SENSE, a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a prospective, randomized, no-treatment controlled clinical trial of a proposed class III medical device. This study is designed to demonstrate clinical safety and performance of the IPN-21-SENSE dermal filler in the restoration or creation of volume in the mid-face.

The objective of this 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.

Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system.

Effectiveness of IPN-21-SENSE will be demonstrated if the mean volumetric change at 24 weeks after baseline from pre-treatment in the treatment group is statistically superior to the mean change in the delayed treatment (control) group.

In total, approximately 90 subjects will be enrolled across two study centers in France and Poland.

Subjects will be randomized to the treatment group or delayed treatment (control) group at a 5:1 ratio (i.e., there will be 5 more subjects treated with IPN-21-SENSE at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with IPN-21-SENSE at 24 weeks after baseline).

The total duration of subject participation ranges from 18 months (treatment group) to 24 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30 months. ;

Related Conditions & MeSH terms

• Aesthetics
• Aging

• NCT number: NCT05747456
• Study type: Interventional
• Source: Laboratoires Vivacy
• Contact: Amandine PARLANTI, MSc
• Phone: 00 33 4 50 31 71 81
• Email: a.parlanti@vivacy.fr
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Completion date: September 30, 2025