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

NCT04505319 | Completed

• 1 other identifier: ReGl/19/Dfc-Res/001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aesthetics; Intradermal Injections

Keywords

DERMAL FILLER; sodium hyaluronate; RELIFE

Outcome Measures

Primary Outcomes (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.

  one month after injection (first visit from Day 0)

Secondary Outcomes (10)

• Global aesthetic improvement during follow up

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

• Clinical evaluation on restoration and/or augmentation of facial volume

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

• Need of a touch-up injection

  after one month of injection (Month 1)

• Objective evaluation on restoration and/or augmentation of facial volume

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

• subject satisfaction on Aesthetic improvement

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

Study Arms (1)

DEFINISSE CORE FILLER

EXPERIMENTAL

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.

Device: DEFINISSE CORE FILLER

Interventions

DEFINISSE CORE FILLER 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

DEFINISSE CORE FILLER

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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).
• Subject agreeing to keep their usual cleansing / care products on the face during the whole study period;
• Whole full teething subjects

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Relife S.r.l.: lead

Study Sites (1)

Eurofins Laboratoire Dermscan

Villeurbanne, 69100, France

Location

Study Officials

• Siham RHARBAOUI

  Eurofins Laboratoire Dermscan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * prospective, * non comparative * single centre, * on healthy subjects.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 10, 2020
• Study Start: September 14, 2020
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)