AgingHEBE2NCT05609617
Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA®
A study testing injection and Cream application in people with Aging, run by Laboratoires FILLMED at 1 site in France.
Trial summary
The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- injection and Cream application
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2019to 7 Nov 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥19 years old;
- Subject who has signed a written informed consent;
- Subject with a Fitzpatrick phototype of I, II, III or IV
- Subject with a grade of photoaging of 2 or 3 on a scale of Glogau
- Subject having a wrinkle score according to Lemperle scale of 2, 3 or 4 at the level of periorbital lines
- Subject having at least:
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- a Grade 1, 2, 3 or 4 on Bazin Neck Wrinkle Scale (at least N=30 subject for the control group)
- or a Grade 2, 3 or 4 on Landau Décolleté Wrinkle Scale (at least N=30 subject for the control group)
- Subject registered in social security system or other health insurance regimen
- Subject accepting not to expose Him/herself to the sun or ultraviolet (UV) during the entire duration of the study.
- Female subject accepting to take a pregnancy test.
Who cannot join
- Subject involved in any other clinical study evaluating drugs or medical devices or subjects in exclusion periods of another clinical study.
- Subject deprived of freedom by an administrative or legal decision
- Unable to follow protocol requirements.
- Subject who has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study).
- Subject having benefited from injection/facial implantation of any non-absorbable filling agent at any time of his/her life.
- Subject 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 27Show fewer
- Subject with a history of fillers injections (hyaluronic acid type) in the last year or botulinum toxin in the last 6 months or the injectable implants (semi-permanent fillers) in the last two years.
- Subject with a skin support device (wire mesh, gold wire, liquid silicone or other particulate material) at the study zones.
- Subject having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months.
- Subject with a history of multiple severe allergies or anaphylactic shock.
- Subject with a known hypersensitivity to hyaluronic acid, or other components of the NCTF 135HA solution.
- Subject with known intolerance/hypersensitivity to any cosmetic topical products, hyaluronic acid and/or other components of Hydra-Filler ® FILORGA Moisturizing Cream.
- Subject with a known hypersensitivity to chlorhexidine.
- Subject 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.
- Subject with a history of streptococcal diseases (angina recurrent, rheumatic fever).
- Subject 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).
- Subject under concomitant treatment (or not stopped for at least 1 year) by immunosuppressive or chemotherapy treatments.
- Subject with a history of less than one year of radiation therapy at the head and neck.
- Subject with an associated antecedent or pathology of autoimmune or connective tissue disease.
- Subject 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.
- Subject having taken aspirin or anticoagulants, at regular doses, in the last 15 days preceding the act.
- Subject that has been exposed to sun or UV in the last 15 days.
- Subject 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).
- Subject having epilepsy uncontrolled by treatment.
- Subject 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA® Medical Device, on Filling the Superficial Wrinkles and on Skin Quality: HEBE2 Study
The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles.
Read the detailed description
Aging is a complex phenomenon that includes many structural changes over time. At the level of the face, the ageing of the superficial plane (skin) and that of the support structures (fat, muscles and bones) are distinguished. On the skin, there is a reduction in cell renewal, dehydration, loss of radiance, elasticity, firmness and the appearance of fine lines and wrinkles. The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the nature of the process under study, it is difficult to propose as a control a solution that includes only saline as an injection product. Indeed, the subject would suffer harm related to injections without a priori benefiting from them. In addition, a DM injected using a multi-injection technique is a whole combining micro-injections by themselves and the products injected. Therefore, it is proposed to use as a control group subjects who will be evaluated in a similar way to those treated by injections of the biorevitalization solution but whose only cosmetic care will consist of the application of a moisturizing cream. This cream, used daily, will also be applied by the subjects in the injection group Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles. For the face, this criterion will be the evolution of the average volume of crow's feet wrinkles (depth and surface). It will be measured centrally by a validated 3D imaging technique. For the neck and décolleté areas that will also be studied, this assessment will be replaced by clinical scoring using photographic scales developed specifically for these areas (the typology of this type of wrinkle does not lend itself to conventional 3D analysis measurements). This evaluation will be completed by a series of other dermatological explorations, also non-invasive: clinical scoring, measurement of skin hydration, elasticity, photographic evaluation of skin ageing and measurement of dermal density by high frequency ultrasound
- Conditions
- Aging
- Being tested
- injection, Cream application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectionDevice
Intradermal injection on the face and neck/or décolleté by the NCTF135 HA
Cream applicationOther
Application of hydra filler cream on the face and neck/or décolleté
| Study group | Role | What they receive |
|---|---|---|
| Face and neck injection | Experimental | NCTF135HA intradermal injection on face and neck. 3 injections spaced out by two weeks; injection points are spaced every 1-1.5 cm with a quantity of 0.05 ml on each point.
Application of Hydra Filler cream twice daily on the face and neck. Receives: Device: injection |
| Face and upper chest/décolleté injection | Experimental | NCTF135HA intradermal injection on face and décolleté. 3 injections spaced out by two weeks; injection points are spaced every 1-1.5 cm with a quantity of 0.05 ml on each point.
Application of Hydra Filler cream twice daily on the face and décolleté. Receives: Device: injection |
| Face and neck controle | Active comparator | Application of Hydra Filler cream twice daily on the face and neck. Receives: Other: Cream application |
| Face and upper chest/décolleté controle | Active comparator | Application of Hydra Filler cream twice daily on the face and décolleté. Receives: Other: Cream application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of the mean volume of crow's feet wrinkles for the face at Day 75
Change from Baseline of the mean volume of crow's feet wrinkles for the face at Day 75 e (depth and surface) in mm^3 measured by LifeViz 3D micro® of injected group compared to control group
Measured: Day 75 (75 days after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start11 Jun 2019
- Primary completion17 Sep 2019
- Study completion7 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 145 subjects divided into 2 groups (Randomization 3:1 for the face): • 107 subjects in treatment group on the face. Among these patients, N=55 were injected on the neck and N=49 on the décolleté. 38 patients were included in the control group. Among these patients, all were studied on the neck and N=34 were studied on the décolleté
- Masking
- None (open label)
- Enrolment
- 146 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
- NCT05609617
- Sponsor's protocol ID
- HEBE2: 2018-A03167-48
- Other IDs
- 2018-A03167-48
- Acronym
- HEBE2
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanian F, Deutsch JJ, Bousquet MT, Boisnic S, Andre P, Catoni I, Beilin G, Lemmel C, Taieb M, Gomel-Toledano M, Issa H, Garcia P. A hyaluronic acid-based micro-filler improves superficial wrinkles and skin quality: a randomized prospective controlled multicenter study. J Dermatolog Treat. 2023 Dec;34(1):2216323. doi: 10.1080/09546634.2023.2216323. Epub 2023 Aug 14.
PubMed 37577796
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA® Medical Device, on Filling the Superficial Wrinkles and on Skin Quality: HEBE2 Study
- ClinicalTrials.gov ID
- NCT05609617
- Acronym / sponsor ID
- HEBE2 / HEBE2: 2018-A03167-48
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Laboratoires FILLMEDIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 8 Nov 2022 (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.
The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles.
Detailed description
Aging is a complex phenomenon that includes many structural changes over time. At the level of the face, the ageing of the superficial plane (skin) and that of the support structures (fat, muscles and bones) are distinguished. On the skin, there is a reduction in cell renewal, dehydration, loss of radiance, elasticity, firmness and the appearance of fine lines and wrinkles. The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the nature of the process under study, it is difficult to propose as a control a solution that includes only saline as an injection product. Indeed, the subject would suffer harm related to injections without a priori benefiting from them. In addition, a DM injected using a multi-injection technique is a whole combining micro-injections by themselves and the products injected. Therefore, it is proposed to use as a control group subjects who will be evaluated in a similar way to those treated by injections of the biorevitalization solution but whose only cosmetic care will consist of the application of a moisturizing cream. This cream, used daily, will also be applied by the subjects in the injection group Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles. For the face, this criterion will be the evolution of the average volume of crow's feet wrinkles (depth and surface). It will be measured centrally by a validated 3D imaging technique. For the neck and décolleté areas that will also be studied, this assessment will be replaced by clinical scoring using photographic scales developed specifically for these areas (the typology of this type of wrinkle does not lend itself to conventional 3D analysis measurements). This evaluation will be completed by a series of other dermatological explorations, also non-invasive: clinical scoring, measurement of skin hydration, elasticity, photographic evaluation of skin ageing and measurement of dermal density by high frequency ultrasound
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 145 subjects divided into 2 groups (Randomization 3:1 for the face): • 107 subjects in treatment group on the face. Among these patients, N=55 were injected on the neck and N=49 on the décolleté. 38 patients were included in the control group. Among these patients, all were studied on the neck and N=34 were studied on the décolleté
| Arm | Type | Receives |
|---|---|---|
| Face and neck injection | Experimental | Device: injectionNCTF135HA intradermal injection on face and neck. 3 injections spaced out by two weeks; injection points are spaced every 1-1.5 cm with a quantity of 0.05 ml on each point. Application of Hydra Filler cream twice daily on the face and neck. |
| Face and upper chest/décolleté injection | Experimental | Device: injectionNCTF135HA intradermal injection on face and décolleté. 3 injections spaced out by two weeks; injection points are spaced every 1-1.5 cm with a quantity of 0.05 ml on each point. Application of Hydra Filler cream twice daily on the face and décolleté. |
| Face and neck controle | Active comparator | Other: Cream applicationApplication of Hydra Filler cream twice daily on the face and neck. |
| Face and upper chest/décolleté controle | Active comparator | Other: Cream applicationApplication of Hydra Filler cream twice daily on the face and décolleté. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects ≥19 years old;
- Subject who has signed a written informed consent;
- Subject with a Fitzpatrick phototype of I, II, III or IV
- Subject with a grade of photoaging of 2 or 3 on a scale of Glogau
- Subject having a wrinkle score according to Lemperle scale of 2, 3 or 4 at the level of periorbital lines
Key exclusion criteria (27 listed)
- Subject involved in any other clinical study evaluating drugs or medical devices or subjects in exclusion periods of another clinical study.
- Subject deprived of freedom by an administrative or legal decision
- Unable to follow protocol requirements.
- Subject who has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study).
- Subject having benefited 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 |
|---|---|---|
| injectionIntradermal injection on the face and neck/or décolleté by the NCTF135 HA | Device | Face and neck injection, Face and upper chest/décolleté injection |
| Cream applicationApplication of hydra filler cream on the face and neck/or décolleté | Other | Face and neck controle, Face and upper chest/décolleté controle |
Primary outcome
Change from Baseline of the mean volume of crow's feet wrinkles for the face at Day 75
Time frame: Day 75 (75 days after the injection
Change from Baseline of the mean volume of crow's feet wrinkles for the face at Day 75 e (depth and surface) in mm^3 measured by LifeViz 3D micro® of injected group compared to control group
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 8 Nov 2022.
- Derived from this study: PubMed 37577796Fanian F, Deutsch JJ, Bousquet MT, Boisnic S, Andre P, Catoni I, Beilin G, Lemmel C, Taieb M, Gomel-Toledano M, Issa H, Garcia P. A hyaluronic acid-based micro-filler improves superficial wrinkles and skin quality: a randomized prospective controlled multicenter study. J Dermatolog Treat. 2023 Dec;34(1):2216323. doi: 10.1080/09546634.2023.2216323. Epub 2023 Aug 14.
- Individual participant dataSharing planned: No
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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 injection and Cream application in people with 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 27 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 8 Nov 2022. 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?
Change from Baseline of the mean volume of crow's feet wrinkles for the face at Day 75 (time frame: Day 75 (75 days after the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05609617, which also lists 1 linked publication.
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 8 Nov 2022.