Skin AgingHEBE8NCT07007351
Multicenter, Prospective Study to Determine the Performance and Safety of the New M-HA30 Architect Device on the Quality of the Skin: HEBE8 Study
A study testing Intradermal injection in people with Skin Aging, run by Laboratoires FILLMED at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 84 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- Intradermal injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2023to 13 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- Subject involved in any other clinical study evaluating drugs or medical devices, including devices without an intended medical purpose, or subjects in exclusion periods of another clinical study.
- 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.
Show all 32Show fewer
- 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).
- Under concomitant treatment (or not stopped for at least 1 year) by immunosuppressive or chemotherapy treatments.
- With a history of less than one year of radiation therapy in the investigated areas.
- With an associated antecedent or pathology of autoimmune or connective tissue disease.
- Presenting a skin pathology, an acute inflammatory reaction or a bacterial or viral infection on the study zones or within the 6 weeks after the end of such an episode.
- With heart disease and/or undergoing treatment for heart disease (beta-blockers)
- With congenital glucose-6-phosphate dehydrogenase deficiency or idiopathic methemoglobinemia
- With hepatocellular insufficiency and/or undergoing treatment for liver disease
- With porphyria
- Having taken aspirin or anticoagulants, at regular doses, in the last 15 days preceding the act.
- That has been exposed to sun or UV in the last 15 days.
- With a dermatological condition or inflammation at the treatment zone or near to this area (according to the investigator's judgment).
- Pregnant or lactating woman (Before every injection, a urinary pregnancy test will be performed).
- Having epilepsy uncontrolled by treatment.
- Presenting a general pathology, skin pathology, dermatosis, systemic, chronic or acute disease and/or topical or general treatment that in the opinion of the investigator may interfere with the treatment or compromise the participation of the subject in the study.
- With a COVID vaccination plan of any dose with any kind of vaccine at 3 weeks before or 3 weeks after each injection session.
- With a history of COVID infection in the last 4 weeks and still have a positive test and/or the raised inflammatory markers such as ferritin, CRP, IL-8, D-Dimer, etc. (blood results will only be requested for volunteers with a severe form of the disease, i.e. one that required medical intervention or hospitalization).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Intradermal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injectionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Intradermal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Very shallow wrinkle
- Fine wrinkle
- Fine to moderate wrinkles
- Moderate wrinkle
- Deep wrinkle
- Very deep wrinkle
Measured: Between Day 0 and Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start19 Mar 2023
- Primary completion13 Apr 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires FILLMED
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007351
- Sponsor's protocol ID
- 2022-A00173-40
- Other IDs
- CIV-22-09-040866
- Acronym
- HEBE8
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07007351
- Acronym / sponsor ID
- HEBE8 / 2022-A00173-40
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Laboratoires FILLMEDIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2023 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| MHA30 injected on the Left (Split face study) for Face and Neck (Décolleté is not comparative) | Experimental | Device: Intradermal injectionIn 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). |
| MHA-30 injected on the Right (Split face study) for Face and Neck (Décolleté is not comparative) | Experimental | Device: Intradermal injectionIn 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). |
Who may qualify
- Ages
- 19 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (32 listed)
- Subject involved in any other clinical study evaluating drugs or medical devices, including devices without an intended medical purpose, or subjects in exclusion periods of another clinical study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal injectionThe product is the first solution with free hyaluronic acid boosted with silicium the administration mode is same as any other intradermal multi-injection procedure | Device | 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) |
Primary outcome
Universal wrinkles score
Time frame: Between Day 0 and Day 40
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal injection in people with Skin Aging, run by Laboratoires FILLMED at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Universal wrinkles score (time frame: Between Day 0 and Day 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.