Mild to medium lines and depressions (mild to moderate nasolabial folds) and shallow to moderate marionette lines Skin and Connective Tissue Diseases
Conditions
Interventions
1. 35 subjects minimum for group 1 with nasolabial fold (NLF) treatment
2. 35 subjects minimum for group 2 with marionette lines (ML) treatment
A subject can be included in both groups
The Perfectha
Sponsors
Sinclair Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sex: female or male 2. Age between 25 and 65 years 3. Subject seeking an improvement of her/his face aspect with a hyaluronic acid filler product 4. Subject presenting mild to medium lines and depressions such as: 4.1. Mild to moderate NLFs (score 2 or 3 on both sides of the face [identical score on both sides required] on the Wrinkle Severity Rating Scale [WSRS]) as assessed live by the independent investigator and/or 4.2. Shallow to moderate marionette lines (score 1 or 2 on both sides of the face [identical score on both sides required] on the Marionette Lines Grading Scale [MLGS]) as assessed live by the independent investigator 5. The extent(s) of the subject’s nasolabial folds or marionette lines is/are sufficient that it is possible to achieve at least a 1-point improvement on the WSRS or MLGS scale with study intervention based on the judgement of the live independent investigator 6. Subject having given freely and expressly his/her informed consent and data privacy consent 7. Subject affiliated with a health social security system 8. Subject willing to have photographs of the face taken and who are willing to provide approval for the use of their study data and anonymized photographs in published literature 9. Subject willing and able to comply with study follow-up procedures and schedule 10. Females of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during the study. 11. Subjects willing to commit to having no further facial aesthetic treatments for the duration of the study period, including follow-up: 11.1. For the subjects treated in NLF, no treatment in the mid-face/cheeks and nose area 11.2. For the subjects treated in ML: no treatment on the lips or nose
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing woman or planning a pregnancy during the study 2. Subject who has 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 is an employee of the investigational site, the CRO or the study sponsor 5. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make-up) 6. Subject with major dental problems or major dental procedure within 6 weeks before screening visit or planned during the study 7. Subject under epidemiologic surveillance or in quarantine linked to the COVID-19 pandemic 8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety 9. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency 10. Subject with uncontrolled epilepsy 11. Subject with porphyria 12. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement) 13. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (recurrent herpes, acne, rosacea) on or around the mouth within 6 months of the study entry 14. Subject predisposed to keloids or hypertrophic scarring 15. Subject with known bleeding/clotting disorder or is receiving medication that will likely increase the risk of bleeding during treatment (taking thrombolytics, anticoagulants, aspirin, non-steroidal anti-inflammatory drugs or vitamin C) during 10 days before each injection 16. Subject with a known history of precancerous lesions/skin malignancies on the face 17. Subject with hypersensitivity or with known allergy to hyaluronic acid, lidocaine, amide-type local anaesthetics, avian proteins, feathers and egg or to one of the antiseptic solutions (chlorhexidine) 18. Subject with a known history of severe allergy or anaphylactic shock 19. Subject having received any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of effectiveness and safety 20. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta-blockers) 21. Subject having received treatment with a laser or UV, dermabrasion, deep chemical peel, prolonged sun exposure or any other procedure based on active dermal response on/around the treated area within the past 6 months 22. Subject having received surgery anywhere on the face within the past 6 months (12 months of washout are required for the cervicofacial lifting and rhinoplasty) 23. Subject having received within the past 12 months any hyaluronic acid filler treatment anywhere in the face 24. Subject having received within the past 24 months any semi-permanent filler (e.g., CaHA, poly-L-lactic acid) anywhere in the face or having received anytime any botulinum toxin or semi-permanent filler on the treated areas 25. Subject having received at any time a fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) on the face 26. Subjects with subcutaneous retaining structure on the face (meshing, threads, gold strand etc) 27. Subject having started or changed his/her oral contraceptive or any other hormonal treatment during 12 weeks prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aesthetic Improvement is measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by an independent live assessor 3 months after treatment (M3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Aesthetic improvement is measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by a live assessor 1 month (M1), 6 (M6) and 9 months (M9) after treatment 2. Aesthetic improvement is measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjects at M1, M3, M6 and M9 3. Improvement of treated areas is measured using Wrinkle Severity Rating Scale (WSRS) and/or Marionette Lines Grading Scale (MLGS) scale evaluated by an independent live assessor at baseline, M1, M3, M6 and M9 4. Improvement of treated areas is measured using WSRS and/or MLGS scale evaluated by a blinded assessor on photographs at baseline, M1, M3, M6 and M9 5. Subject satisfaction is measured using an internal questionnaire at baseline, M1, M3, M6 and M9 6. Injector satisfaction is measured using an internal questionnaire after injection at D0 and M1 7. Procedural pain is measured using a 0 to 10 points pain scale at D0 and M1 after injection 8. Safety is measured using injection site reactions (ISR) rated by a live assessor and by the subjects and by collection of adverse events after treatment, at M1, M3, M6 and M9 | — |
Countries
France
Outcome results
None listed