Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 11:43 AM
Study NCT ID:
NCT07007351
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter, Prospective Study to Determine the Performance and Safety of the New M-HA30 Architect Device on the Quality of the Skin: HEBE8 Study
Sponsor:
Laboratoires FILLMED
Organization:
Study Overview
Official Title:
Comparative, Prospective, Single-blinded, Randomized, Multi-Center Clinical Trial to Determine the Performance and Safety of a New Device Injectable Micro-filler Solution Based on Hyaluronic Acid M-HA®30 Architect on the Skin Quality of the Face, Neck and décolleté and Comparing to a Reference Product, Profhilo® on the Lower Part of the Face and Neck: HEBE 8 Study
Status:
COMPLETED
Status Verified Date:
2025-05
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:
HEBE8
Brief Summary:
For skin rejuvenation the targeted population does not present a specific pathology. Aesthetic procedures are requested by the patient to improve appearance, look younger and feel better.
Non-crosslinked Hyaluronic acid (HA) is widely used by intradermal multiple injection as it is a glycosaminoglycan, which binds and retains water thus improving the wrinkles while the tone and elasticity of the skin.
Previous studies showed that an important administration of Si had benefic effects on bone development, skin ageing and fragile hair and nails.
The major issue of the Si intake is the rapid absorption and excretion, and consequently low effects on the skin. Moreover, with ageing, gastric pH become more acidic and decreases the conversion capacity of the Si.
All these data together led Laboratoires Fillmed to develop an HA product boosted by Si to inject into ther dermis in order to fill fine lines wrinkes and improve skin quality.
This study aims to demonstrate the efficacy of this new Hyaluronic Acid based filler versus a reference device, with an intradermal multi-injection technique, on reducing the superficial wrinkles measured by comparative evaluation between baseline and D30+10 of the evolution of wrinkles of the face / neck and décolleté by clinical scoring.
To this end, subjects in whom a correction of wrinkles of the face and/or décolleté and/or neck is sought, will be included. Subjects will receive 2 sessions of treatment on each side of the concerned area and the aesthetic correction will be appreciated at 10 ± 2 days (D30+10) following the last treatment session and the maintenance of the correction will be evaluated on D60, D120 and D180.
Main objective:
The main objective of this randomized study is to demonstrate objectively the effectiveness of the studied device, on the reduction of the universal wrinkles score, performed in presence of the subjects, between baseline and D30+10 (10 days after the last injection) on the cheeks, neck or décolleté and its non-inferiority by intraindividual comparison versus a reference device for the cheek and the neck.
Secondary objectives:
* For all groups and for the concerned zones:
\- to assess the efficacy of the devices between baseline and D180 (including D0, D30+10, D60, D120 and D180) and comparatively evaluate the efficacy for the cheeks and neck of the tested device compared to the reference device on:
* the Universal Wrinkles Score performed on the cheek's wrinkles, neck wrinkles or décolleté's wrinkles by the investigators, in presence of the subjects
* Zone-specific (cheek, neck or décolleté) clinical scores performed from photographical visual scales, Clinical score of radiance (for the face)
* the Universal Wrinkles Score performed at the end of the study in a blind manner by an expert on the cheek's wrinkles, neck wrinkles or décolleté's wrinkles from the standardized photographs
\- to assess the efficacy of the devices from D30 to D180 on the Global Aesthetic Improvement Scores performed by:
* the investigator (IGAIS) for 5 items
* the subjects (SGAIS) for 5 items
* to assess the safety, efficacy and the opinion of the subjects by a questionnaire
* to illustrate the efficacy of the devices by standardized photographs
Three Research Centerswere added to the study to have objective and instrumental data on the efficacy of the products on skin's:
* hydration by Corneometer®
* firmness and elasticity by CutoMeter®
* density by Ultrasound Imaging
* anatomical characteristics by in vivo Reflectance Confocal Microscopy
* anatomical characteristics by in vivo Optical Coherence Tomography
* the average volume of wrinkles (depth and surface) measured on the cheeks from image processing performed from 3D imaging
Non-crosslinked Hyaluronic acid (HA) is widely used by intradermal multiple injection as it is a glycosaminoglycan, which binds and retains water thus improving the wrinkles while the tone and elasticity of the skin.
Previous studies showed that an important administration of Si had benefic effects on bone development, skin ageing and fragile hair and nails.
The major issue of the Si intake is the rapid absorption and excretion, and consequently low effects on the skin. Moreover, with ageing, gastric pH become more acidic and decreases the conversion capacity of the Si.
All these data together led Laboratoires Fillmed to develop an HA product boosted by Si to inject into ther dermis in order to fill fine lines wrinkes and improve skin quality.
This study aims to demonstrate the efficacy of this new Hyaluronic Acid based filler versus a reference device, with an intradermal multi-injection technique, on reducing the superficial wrinkles measured by comparative evaluation between baseline and D30+10 of the evolution of wrinkles of the face / neck and décolleté by clinical scoring.
To this end, subjects in whom a correction of wrinkles of the face and/or décolleté and/or neck is sought, will be included. Subjects will receive 2 sessions of treatment on each side of the concerned area and the aesthetic correction will be appreciated at 10 ± 2 days (D30+10) following the last treatment session and the maintenance of the correction will be evaluated on D60, D120 and D180.
Main objective:
The main objective of this randomized study is to demonstrate objectively the effectiveness of the studied device, on the reduction of the universal wrinkles score, performed in presence of the subjects, between baseline and D30+10 (10 days after the last injection) on the cheeks, neck or décolleté and its non-inferiority by intraindividual comparison versus a reference device for the cheek and the neck.
Secondary objectives:
* For all groups and for the concerned zones:
\- to assess the efficacy of the devices between baseline and D180 (including D0, D30+10, D60, D120 and D180) and comparatively evaluate the efficacy for the cheeks and neck of the tested device compared to the reference device on:
* the Universal Wrinkles Score performed on the cheek's wrinkles, neck wrinkles or décolleté's wrinkles by the investigators, in presence of the subjects
* Zone-specific (cheek, neck or décolleté) clinical scores performed from photographical visual scales, Clinical score of radiance (for the face)
* the Universal Wrinkles Score performed at the end of the study in a blind manner by an expert on the cheek's wrinkles, neck wrinkles or décolleté's wrinkles from the standardized photographs
\- to assess the efficacy of the devices from D30 to D180 on the Global Aesthetic Improvement Scores performed by:
* the investigator (IGAIS) for 5 items
* the subjects (SGAIS) for 5 items
* to assess the safety, efficacy and the opinion of the subjects by a questionnaire
* to illustrate the efficacy of the devices by standardized photographs
Three Research Centerswere added to the study to have objective and instrumental data on the efficacy of the products on skin's:
* hydration by Corneometer®
* firmness and elasticity by CutoMeter®
* density by Ultrasound Imaging
* anatomical characteristics by in vivo Reflectance Confocal Microscopy
* anatomical characteristics by in vivo Optical Coherence Tomography
* the average volume of wrinkles (depth and surface) measured on the cheeks from image processing performed from 3D imaging
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIV-22-09-040866 | OTHER | EUDAMED | View |