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

NCT ID: NCT04505319

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2022-04-08

Brief 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.

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.

Conditions

Aesthetics; Intradermal Injections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DEFINISSE CORE FILLER

Cross 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.

Group Type: EXPERIMENTAL

DEFINISSE CORE FILLER

Intervention Type: DEVICE

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

Interventions

DEFINISSE CORE FILLER

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy subject;

2. Sex: female;

3. Age: between 40 and 60 years;

4. BMI between 18 and 25 included.

5. Subject having given freely and expressly his informed consent;

6. Subject with a volume deficit on malar area and requiring a correction using a filler;

7. Subject, psychologically able to understand the study related information and to give a written informed consent;

8. Subject affiliated to a health social security system;

9. 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).

10. Female subjects of childbearing potential must have a negative pregnancy test at the inclusion;

11. Subject agreeing to keep their usual cleansing / care products on the face during the whole study period;

12. Whole full teething subjects

Exclusion Criteria

1. Pregnant or nursing woman or planning a pregnancy during the study.

2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.

3. Subject in a social or sanitary establishment.

4. Subject participating to another research on human beings or being in an exclusion period for a previous study.

5. Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.

6. Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.

7. 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.

8. Subject with unstable weight or planning to do a dietary regime during the study.

9. Subject with too severe mid-face volume deficit.

10. Subjects without teeth or with dental prostheses

11. 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.

12. Subject with known history of or suffering from autoimmune disease and/or immune deficiency

13. 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.

14. 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.

15. Subject predisposed to keloids or hypertrophic scarring.

16. Subject with coagulation and/or homeostasis disorders.

17. Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats;

18. 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;

19. Subject having received injection with a reabsorbable filling product in the face area within the past 12 months prior to inclusion;

20. 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, …);

21. Subject having received at any time a treatment with suspension threads in the face;

22. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety.

23. Subject under medications which may cause lipoatrophy;

24. 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;

25. Subject having received chemotherapy agents, immunosuppressive medications or systemic corticosteroids within 3 months of enrolment and during the study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Relife S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siham RHARBAOUI

Role: PRINCIPAL_INVESTIGATOR

Eurofins Laboratoire Dermscan

Locations

Eurofins Laboratoire Dermscan

Villeurbanne, , France

Countries

France

Other Identifiers

ReGl/19/Dfc-Res/001

Identifier Type: -

Identifier Source: org_study_id