Multicenter, Prospective Study to Determine the Performance and Safety of the New M-HA30 Architect Device on the Quality of the Skin: HEBE8 Study

NCT07007351 | Completed

• 2 other identifiers: 2022-A00173-40CIV-22-09-040866
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

• Universal wrinkles score

  Universal Wrinkles Score (UWS) inspired from the Modified Fitzpatrick Wrinkles Scale. It is a 7 grades score. Score definition 0 No wrinkle 1. Very shallow wrinkle 2. Fine wrinkle 3. Fine to moderate wrinkles 4. Moderate wrinkle 5. Deep wrinkle 6. Very deep wrinkle

  Between Day 0 and Day 40

Study Arms (2)

MHA30 injected on the Left (Split face study) for Face and Neck (Décolleté is not comparative)

EXPERIMENTAL

In assessing the aesthetic performance and safety of devices, the inter-individual variability is very large. As a result, a methodology often used is split-face evaluation , the subject being its own control. Schematically, the area of application (right or left hemiface) is drawn randomly and evaluations are done separately. It is a single blind study: during the injections, the eyes of the subject will be obscured by 2 ocular pads. As the procedure of injection of Profhilo for the face does not include the forehead and crow's feet, comparison will be performed with this device only on the lower part of the face (only M-HA®30 Architect will be injected on the crow's feet and forehead for a non-comparative before-after evolution study). As wrinkles of the décolleté are present mainly in the center of the décolleté, it was decided not to make a comparative on this area (only M-HA®30 Architect will be injected).

Device: Intradermal injection

MHA-30 injected on the Right (Split face study) for Face and Neck (Décolleté is not comparative)

EXPERIMENTAL

In assessing the aesthetic performance and safety of devices, the inter-individual variability is very large. As a result, a methodology often used is split-face evaluation , the subject being its own control. Schematically, the area of application (right or left hemiface) is drawn randomly and evaluations are done separately. It is a single blind study: during the injections, the eyes of the subject will be obscured by 2 ocular pads. As the procedure of injection of Profhilo for the face does not include the forehead and crow's feet, comparison will be performed with this device only on the lower part of the face (only M-HA®30 Architect will be injected on the crow's feet and forehead for a non-comparative before-after evolution study). As wrinkles of the décolleté are present mainly in the center of the décolleté, it was decided not to make a comparative on this area (only M-HA®30 Architect will be injected).

Device: Intradermal injection

Interventions

Intradermal injection DEVICE

The product is the first solution with free hyaluronic acid boosted with silicium the administration mode is same as any other intradermal multi-injection procedure

MHA-30 injected on the Right (Split face study) for Face and Neck (Décolleté is not comparative); MHA30 injected on the Left (Split face study) for Face and Neck (Décolleté is not comparative)

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects except for injections on the décolleté that will only concern women
• From 19 to 84 years old
• Who has signed a written informed consent;
• With a Fitzpatrick phototype of I, II, III or IV
• Having on both sides, one of the 3 following conditions:
• For Face: a wrinkle score according to Lemperle scale of 2, 3 or 4 at the level of the cheeks
• For Neck: a Grade 2, 3 or 4 on Bazin Neck Wrinkle Scale
• For Decollte: a Grade 2 or 3 on Landau Décolleté Wrinkle Scale
• Registered with Social Security (for France)
• Accepting not to expose him/herself to the sun or ultraviolet (UV) during the entire duration of the study.
• For female of childbearing potential accepting to take a pregnancy test (a pregnancy test will be performed before each injection) and a highly effective contraception\* method during whole study.

You may not qualify if:

• Deprived of freedom by an administrative or legal decision.
• Unable to follow protocol requirements.
• Who has received compensation of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study / for France).
• Having benefit from injection/facial implantation of any non-absorbable filling agent at any time of his/her life.
• Having already had laser sessions for skin rejuvenation or a laser facelift in the previous year or a facelift by surgery in the 2 years prior to the study.
• With a history of absorbable fillers injections (such as hyaluronic acid) in the last year or botulinum toxin in the last 6 months or the injectable implants (semi-permanent fillers) in the last two years.
• With a skin support device (wire mesh, gold wire, liquid silicone or other particulate material, absorbable or non-absorbable threads) at the study zones.
• Having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months.
• With a history of multiple severe allergies or anaphylactic shock.
• With a known hypersensitivity to hyaluronic acid, or other components of M-HA®30 Architect and Profhilo®.
• With a known hypersensitivity to the disinfection products such as chlorhexidine and betadine.
• With a known hypersensitivity to lidocaine or to local amide-type anesthetics.
• Prone to developing inflammatory skin conditions or hypertrophic scarring according to investigator judgement.
• With a history of streptococcal diseases (angina recurrent, rheumatic fever).
• Under concomitant treatment (or not stopped for at least 3 months) by oral or injectable corticosteroid (inhaled corticosteroids are allowed as well as a topical corticotherapy not involving the study zones).

Sponsors & Collaborators

• Laboratoires FILLMED: lead

Study Sites (1)

Fillmed Laboratoires

Paris, 75008, France

Location

MeSH Terms

Interventions

Injections, Intradermal

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a split face study (the investigational product could be injected on the left or on the right); the comparator will be injected on the opposite side

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 5, 2025
• Study Start: March 19, 2023
• Primary Completion: April 13, 2024
• Study Completion: June 13, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

FR (1)