HEBE8 Study_M-HA®30 Architect injections for aesthetic use
Research type
Research Study
Full 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.
IRAS ID
320460
Contact name
Ferial Fanian
Contact email
Sponsor organisation
Laboratoires FILL-MED
Clinicaltrials.gov Identifier
CIV-22-09-040866, EUDAMED Number
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
There is a growing demand for aesthetic procedures, requested by individuals to improve their appearance. The
American Society of Plastic Surgeons reports an increase from 652,888 soft tissue filler procedures in 2000, to 2.3
million in 2014. Hyaluronic Acid has become the top injected soft filler agent around the world (1.8 million procedures
reported in 2014).Laboratoires FILL-MED are a leading manufacturer of anti-ageing products, having developed and marketed anti-ageing products for medical aesthetic professionals, plastic surgeons and dermatologists.
This study is a prospective trial to evaluate the performance and tolerability of M-HA®30 Architect on the skin quality of the face, neck and décolleté (area below the chin covering the neck and upper chest).
This study is intended to obtain CE marking of M-HA®30 Architect. Participants randomised to receive treatment on the face or neck will have a comparator product injected on half their face/neck, with M-HA®30 Architect injected on the other half.
M-HA®10 is a CE-marked medical device also developed by Laboratoires FILL-MED, which has been on the market
since 2011. It is composed of non-crosslinked, non-animal sodium hyaluronate and is aimed at restoring the loss of
hyaluronic acid due to skin ageing. It is designed to be injected into the dermis (middle layer of skin) to fill the fine
wrinkles while improving the hydration, radiance and elasticity of the skin. M-HA®30 Architect (the device under study) is a boosted form of M-HA®10 with the addition of Silicium (a chemical element naturally present in the body) and higher concentration of hyaluronic acid, designed to improve skin quality.This is a multi-centre study, with sites across 6 European countries (Austria, France, Germany, Italy, Romania, and the UK). Approximately 282 participants will be enrolled across the 15 planned sites, which will be divided into three
Groups depending on area being treated.REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0104
Date of REC Opinion
23 Mar 2023
REC opinion
Further Information Favourable Opinion