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AestheticsNCT04505319

Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-related Volume Deficit

A study testing DEFINISSE CORE FILLER in people with Aesthetics and Intradermal Injections, run by Relife S.r.l. at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine. Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Aesthetics, Intradermal Injections
What is being tested?
DEFINISSE CORE FILLER
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
14 Sep 2020to 8 Apr 2022
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 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subject;
  • Sex: female;
  • Age: between 40 and 60 years;
  • BMI between 18 and 25 included.
  • Subject having given freely and expressly his informed consent;
  • Subject with a volume deficit on malar area and requiring a correction using a filler;
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  • Subject, psychologically able to understand the study related information and to give a written informed consent;
  • Subject affiliated to a health social security system;
  • Female of childbearing potential using a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study (oral contraceptives, patch contraceptives, injection contraceptives, male condom with intra-vaginal spermicide, diaphragm or cervical cap with spermicide, vaginal contraceptive ring, intrauterine device, surgical sterilization (bilateral tubal ligation), vasectomized partner, or sexual abstinence).
  • Female subjects of childbearing potential must have a negative pregnancy test at the inclusion;
  • Subject agreeing to keep their usual cleansing / care products on the face during the whole study period;
  • Whole full teething subjects

Who cannot join

  • Pregnant or nursing woman or planning a pregnancy during the study.
  • Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
  • Subject in a social or sanitary establishment.
  • Subject participating to another research on human beings or being in an exclusion period for a previous study.
  • Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
  • Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
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  • Subject with a tattoo, a scar, moles, pigment disorders or anything on the studied zones which may interfere with the study at the investigator appreciation.
  • Subject with unstable weight or planning to do a dietary regime during the study.
  • Subject with too severe mid-face volume deficit.
  • Subjects without teeth or with dental prostheses
  • Subject with severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease, neoplasia, malignant blood disease, tumor, HIV, epilepsy, porphyria or other major disease, likely to interfere with the measured parameters or to put the subject to an undue risk.
  • Subject with known history of or suffering from autoimmune disease and/or immune deficiency
  • Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes, mycosis, papilloma, chronic eczema, atopic dermatitis …), abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone.
  • Subject having history of anaphylactic shock or know allergy or hypersensitivity to hyaluronic acid or to one of the components of the tested device, antiseptic solution, lidocaine hydrochloride or to amide-type local anaesthetics.
  • Subject predisposed to keloids or hypertrophic scarring.
  • Subject with coagulation and/or homeostasis disorders.
  • Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats;
  • Subject having received treatment with a laser, a dermabrasion, a surgery, a chemical peeling, mesotherapy or other ablative procedure on the face within the past 12 months prior to inclusion;
  • Subject having received injection with a reabsorbable filling product in the face area within the past 12 months prior to inclusion;
  • Subject having received at any time injection with a slowly reabsorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …);
  • Subject having received at any time a treatment with suspension threads in the face;
  • Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety.
  • Subject under medications which may cause lipoatrophy;
  • Subject using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants, high-doses vitamin C within 10 days prior to inclusion or being a chronic user;
  • Subject having received chemotherapy agents, immunosuppressive medications or systemic corticosteroids within 3 months of enrolment and during the study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Eurofins Laboratoire Dermscan

    Villeurbanne, 69100

Other trials in France

About this study

Official title: Prospective, Single Center Study for the Clinical Evaluation of the Safety and Performance of a Dermal Filler in Correction of Mid-face Age-related Volume Deficit

Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.

Read the detailed description

Prospective, non comparative, single center study, on healthy female subjects. The scope is to evaluate the performance and safety of a dermal filler (definisse core filler plus lidocaine) to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.

Being tested
DEFINISSE CORE FILLER
Keywords
DERMAL FILLER, sodium hyaluronate, RELIFE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEFINISSE CORE FILLERDevice

    DEFINISSE CORE FILLER volume will be injected between 4.0 of 5.0 ml on the whole face (at the discretion of the treating physician to achieve an optimal aesthetic result).

    A touch-up will be possible at the first follow-up visit (after one month) with a amount of product between 4.0 and 5.0 ml on the whole face

Study groups in NCT04505319
Study groupRoleWhat they receive
DEFINISSE CORE FILLERExperimentalCross linked sodium hyaluronate 25 mg/ml with 0,3% lidocaine hydrochloride will be inject during the first visit and a touch up after one month if indicated by the physician. The filler will inject in the face.
Receives: Device: DEFINISSE CORE FILLER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global aesthetic improvement one month

    Clinical evaluation of the global aesthetic improvement (GAIS) one month after injection of the investigational medical device in subjects with mid-face age-related volume deficit.

    Measured: one month after injection (first visit from Day 0)

Secondary outcomes (10)

  1. Global aesthetic improvement during follow up

    Clinical evaluation of the global aesthetic improvement (GAIS) 3, 6, 9, 12 and 18 months after injection of the investigational medical device in subjects with mid-face age-related volume deficit.

    Measured: 3, 6, 9, 12 and 18 months after injection

  2. Clinical evaluation on restoration and/or augmentation of facial volume

    Clinical evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with a clinical scale (FVLS) Face Volume Loss Scale, with a score from Grade 1 to Grade 5, when Grade 1 is the better outcome .

    Measured: from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months

  3. Need of a touch-up injection

    evaluation if a touch up injection is needed after one month

    Measured: after one month of injection (Month 1)

  4. Objective evaluation on restoration and/or augmentation of facial volume

    Objective evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with cheekbone volume variation evaluation by 3D LifeViz® system

    Measured: from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months

  5. subject satisfaction on Aesthetic improvement

    Evaluation of subject satisfaction using a subjective evaluation questionnaire, (GAIS) Global Aesthetic improvement Scale, the scores is from 1 to 5, when 1 is the better outcome.

    Measured: at each time point after injection, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months.

  6. Evaluation of injector satisfaction on using medical device

    Evaluation of injector satisfaction using a subjective evaluation questionnaire

    Measured: During the injection Day 0 and 1 one month after the first injection (Month 1)

  7. evaluation on skin quality after injection with Dermascan

    Objective evaluation of the investigational medical device effect on skin quality using Dermascan instrument

    Measured: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection

  8. evaluation on skin thickness after injection with Dermascan

    Objective evaluation of the investigational medical device effect on skin thickness using Dermascan instrument

    Measured: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection

  9. evaluation onskin biomechanical properties after injection with Cutometer

    Objective evaluation of the investigational medical device effect on skin biomechanical properties measurements using Cutometer

    Measured: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection

  10. Evaluation of product safety

    Clinical evaluation of the investigational medical device safety with Injection Site Reactions (ISRs) and adverse event collection

    Measured: 1 month after each injection for ISRs and 21 months for adverse event collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2020
  2. Study start14 Sep 2020
  3. Primary completion8 Apr 2022
  4. Study completion8 Apr 2022

Resources

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
Not applicable
Intervention model
Single group
Model description
* prospective, * non comparative * single centre, * on healthy subjects.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04505319
Sponsor's protocol ID
ReGl/19/Dfc-Res/001
Status last verified
May 2022
First submitted
30 Jul 2020
Last updated
6 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DEFINISSE CORE FILLER in people with Aesthetics and Intradermal Injections, run by Relife S.r.l. 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 12 inclusion and 25 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 6 May 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?

Global aesthetic improvement one month (time frame: one month after injection (first visit from Day 0)). 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 NCT04505319.

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 6 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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