Mild to moderate tear troughs, moderate to severe perioral wrinkles, shallow to deep periorbital wrinkles Skin and Connective Tissue Diseases
Conditions
Interventions
69 patients will be treated in total with Perfectha® Finelines Lidocaine:
At least 23 subjects will be treated in the tear troughs
At least 23 subjects will be treated in the perioral wrinkles
At le
Sponsors
Sinclair Pharmaceuticals Limited
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 Hyaluronic Acid filler product. 4. Subject with mild to moderate tear troughs (score 1 to 2 on the Barton scale) and/or Subject with moderate to severe perioral wrinkles (score 2 to 6 on the upper lip wrinkles Bazin scale). and/or Subject with shallow to deep crow’s feet wrinkles, also known as periorbital wrinkles (score 2 to 4 on the Lemperle periorbital lines scale) 5. Subject having given freely and expressly his/her informed consent and data privacy consent. 6. Subject willing to have photographs of the face taken and willing to provide approval for the use of their study data and anonymized photographs in published literature. 7. Subject willing and able to comply with study follow-up procedures and schedule. 8. Subject affiliated to a health social security system. 9. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during all the study. 10. Subject willing to commit to having no further facial aesthetic treatments for the duration of the study period, including followup: 10.1. For the subjects treated in tear troughs, no treatment in the mid-face, tear troughs, periorbital lines below the eyes and nose area. 10.2. For the subjects treated in perioral wrinkles, no treatment in the nose, lips and perioral area. 10.3. For the subjects treated in periorbital wrinkles, no treatment in the periorbital, temples and nose area
Exclusion criteria
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 is an employee of the investigational site, the CRO or 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. For subjects treated in perioral wrinkles: subject with major dental problems or major dental procedure withing 6 weeks before screening visit or planned during the study. 7. Subject not eligible for scientific reasons at the interpretation of the investigator. 8. Subject under epidemiologic surveillance / in quarantine linked to the COVID-19 pandemic. 9. Subject having a medical history which may interfere, at the interpretation of the investigator, with the study objectives in term of effectiveness and safety. 10. 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. 11. Subject with known history of or suffering from autoimmune disease and/or immune deficiency. 12. Subject with uncontrolled epilepsy. 13. Subject with porphyria. 14. Subject with known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement). 15. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (recurrent herpes, acne, rosacea...) on or around the eyes and lips within 6 months of the study entry. 16. Subject predisposed to keloids or hypertrophic scarring. 17. Subject with known bleeding/clotting disorder or is receiving medication that will likely increase the risk of bleeding during treatment (taking thrombolytics, anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs or vitamin C) during 10 days before each injection. 18. Subject with known history of precancerous lesions/skin malignancies on/around the eyes and lips. 19. Subject with hypersensitivity or with known allergy to: hyaluronic acid, lidocaine, local disinfectant containing quaternary ammonium salts, amide type local anaesthetics, avian proteins, feathers and egg or to one of the antiseptic solution. 20. Subject with known history of severe allergy or anaphylactic shock. 21. Subject having received any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of effectiveness and safety. 22. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta blockers). 23. 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 eyes and lips within the past 6 months. 24. Subject having received a surgery anywhere on the face within the past 6 months (12 months of washout are required for the cervicofacial lifting and rhinoplasty). 25. Subject having received within the past 12 months any hyaluronic acid filler treatment or having received at any time fillers of animal origin, implant containing a substance other than hyaluronic acid, permanent implants, autologous fat transfer or threading surgery: 25.1. For the subjects treated in tear troughs, in the mid-face, tear troughs, periorbital lines bel
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 (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. Subject satisfaction is measured using an internal questionnaire at baseline, M1, M3, M6 and M9. 4. Injector satisfaction is measured using an internal questionnaire at D0 and M1 after injection. 5. Improvement of tear troughs measured using Barton's scale is evaluated by a blinded independent assessor on photographs at baseline, M1, M3, M6 and M9. 6. Improvement of perioral wrinkles severity measured using the upper lip wrinkles scale from Bazin is evaluated by a blinded independent assessor on photographs at baseline, M1, M3, M6 and M9. 7. Improvement of crow’s feet wrinkles severity measured using the crow’s feet wrinkles Bazin scale is evaluated by a blinded independent assessor on photographs at baseline, M1, M3, M6 and M9. 7. Prodedural pain is measured by the subjects 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