Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747456
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-02-17
Brief Title:
Study of a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face FaceHyal
Sponsor:
Laboratoires Vivacy
Organization:
Laboratoires Vivacy
Study Overview
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FaceHyal
Brief 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
Detailed 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 51 ratio ie 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
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 51 ratio ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None