Subjects presenting moderate to severe facial aging signs, including perioral lines, nasolabial folds, infraorbital hollows, cheek/chin volume loss, or thin lips, seeking aesthetic improvement through dermal filler injection. Skin and Connective Tissue Diseases
Conditions
Interventions
HAR device is sterile, transparent and resorbing gel of crosslinked (with BDDE) hyaluronic acid of non-animal origin.
The indication for use of the HAR devices is the aesthetic modification of the
Sponsors
Louna Aesthetics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy Subject. 2.Sex: male or female. 3.Age: between 18 and 70 years. 4.Subject seeking an improvement of her/his face aspect with HA filler. 5.*For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) and/or subject seeking improvement of infraorbital hollow enhancement. *For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on WSRS scale) and/or subjects with mild to moderate cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale); *For group 3: Subject with thin lips (score 1 or 2 for superior and/or inferior lip on the Rossi scale) and seeking an improvement of lip volume *For group 4: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale) and/or subject seeking improvement of chin enhancement. 6.Subject with a stable weight since the last 6 months and who agree to keep a stable weight during the study. 7.Subject having given freely and expressly his/her informed consent. 8.Subject psychologically able to understand the study related information and to give a written informed consent. 9.Subject affiliated to a health social security system. 10.Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks and during all the study.
Exclusion criteria
Exclusion criteria: In terms of population: 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 suspected to be non-compliant according to the investigator’s judgment. 5. Subject having received a total of 6.000 euros as compensations for her/his participation in clinical research in the last 12 months, including their participation in the present study. 6. Subject enrolled in another study or whose non-enrollment period is not over. 7. Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up…). In terms of associated pathology: 8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety. 9. Subject with known history of or suffering from autoimmune disease and/or immune deficiency. 10. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, severe acne, severe rosacea, porphyria …) in the 6 months before screening visit. 11. Subject with a history of streptococcal disease or an active streptococcus infection. 12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders. 13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders. 14. Subject having history of severe allergy or anaphylactic shock including known hypersensitivity to one of the components of the investigational device (i.e Hyaluronic acid), to antiseptic solution (Diaseptyl®), to lidocaine or to amide-type anaesthetics 15. Subject with symptoms consistent with COVID-19 or are suffering from ongoing symptoms from previous COVID-19 infection[CC1.1] Relating to previous or ongoing treatment: 16. Any medication which may interfere, at the interpretation of the investigator, with the study objectives. 17. Subject having received treatment with a laser, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face within the past 6 months or who plans to undergo any of these procedures during the study. 18. Subject having received within the past 18 months or planning to receive during the study any injections outside of those in the study protocol including non-permanent and semi-permanent fillers (e.g., HA, Calcium Hydroxyapatite) or botulinum neurotoxin [CC2.1]on or near the treated zone. 19. Subject having received within the past 9 months or planning to receive during the study mesotherapy injections on or near the treated zone.[CC3.1] 20. Subject having received at any time or planning to receive a permanent filler on the face (e.g., polylactic acid, Polymethylmethacrylate, silicone) during the study. 21. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand). 22. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit or being a chronic user. 23. Subject undergoing a topical treatment on the test area or a systemic treatment: 23.1. anti-inflammatory medication and/or antihistamines within the past 2 weeks and during the study, 23.2. corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of the zone treated with the overall HAR range of devices as assessed by an independent investigator, one month (M1) after treatment, using the GAIS. An improvement is defined as a subject with “very much improved”, “much improved” or “improved” score on the GAIS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Injection Site Reaction six month (M6) and twelve month (M12) after treatment as evaluated by an independent investigator 2. Injection Site Reaction one month (M1), six month (M6) and twelve month (M12) after treatment as evaluated by the subjects. 3. AEs throughout the study 4. Improvement of the zone treated with the overall HAR range of devices as assessed by an independent investigator, six (M6) and twelve (M12) months after treatment, using the GAIS. 5. Improvement of the zone treated with each HAR device for all indications independently as assessed by the independent investigator, one, six and twelve months after treatment, using the GAIS. 6. Improvement of the zone treated with the HAR range of devices overall as assessed by the subjects, one, six and twelve months after treatment, using the GAIS. 7. Improvement of the zone treated with each HAR device for all indications independently as assessed by the subjects, one, six, and twelve months after treatment, using the GAIS 8. Effectiveness on wrinkles/lines filling of the device HAR 1 used in the peri-oral lines as assessed by the independent investigator one, six and twelve months after treatment, using the Bazin Upper lip wrinkles scale. 9. Effectiveness on folds filling of the device HAR 2 used in the nasolabial folds as assessed by the independent investigator one, six and twelve months after treatment, using the WSRS scale. 10. Effectiveness on volume restauration of the device HAR 2 used in the cheeks/cheekbones as assessed by the independent investigator, one, six and twelve months after treatment, using the Ascher lipoatrophy scale. 11. Effectiveness on lip volume increase of the device HAR 2 used in lips as assessed by the independent investigator one, six and twelve months after treatment, using the Rossi scale. 12. Effectiveness on volume restauration of the device HAR 3 used in the cheeks/cheekbones as assessed by the independent investigator, one, six and twelve months after treat | — |
Countries
France
Contacts
Public ContactSiham Rharbaoui
Outcome results
None listed