For Perfectha® Derm Lidocaine: very thin to thin lip volume and with lip contour somewhat well-defined to poorly defined
Conditions
Interventions
34 will be included in group 1 and treated for lip contour definition and lip volume with Perfectha® Derm Lidocaine.
34 will be included in group 2 and treated for lip volume with Perfectha® Deep Lido
Sponsors
Sinclair Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sex: female or male 2. Age: between 18 and 65 years 3.1. For group 1: subject seeking treatment for lip volume and for lip contour redefinition 3.2. For group 2: subject seeking treatment for lip volume 4.1. For group 1: subject with very thin to thin lip volume (grade 1 to 2 for superior and/or inferior lip on the Rossi scale) and with lip contour somewhat well-defined to poorly defined (grade 2 or 3 on the Draelos vermilion border scale) 4.2. For group 2: subject with thin to moderate lip volume (grade 2 to 3 for superior and/or inferior lip on the Rossi 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 who are 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 with 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 the study 10. Subject willing to commit to having no further facial aesthetic treatments on the nose, lips, perioral lines and marionette lines for the duration of the study period, including follow-up
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 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 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 terms 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 a known history of or suffering from autoimmune disease and/or immune deficiency 12. Subject with uncontrolled epilepsy 13. Subject with porphyria 14. Subject with a 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 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, non-steroidal anti-inflammatory drugs or vitamin C) during 10 days before each injection 18. Subject with a known history of precancerous lesions/skin malignancies on/around the 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 a 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 terms 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 lips within the past 6 months 24. Subject having received surgery anywhere on the face within the past 6 months (12 months of washout are required for the cervicofacial lifting) 25. Subject having received within the past 12 months any hyaluronic acid filler treatment on the lips, perioral lines, marionette lines or nose. Injection in the areas listed above, to gain access to other areas of the face, are also non-allowable 26. Subject having received at any time fillers of animal origin, implant containing a substance other than hyaluronic acid, permanent or semi-permanent implants, autologous fat transfer or threading surgery on the lips, perioral lin
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. Improvement of treated areas is measured using Rossi and/or Draelos vermillion border evaluated by an assessor on photographs at baseline, M1, M3, M6 and M9 4. Subject's satisfaction is measured using an internal questionnaire at baseline, M1, M3, M6 and M9 5. Injector satisfaction is measured using an internal questionnaire after injection at D0 and M1 6. Procedural pain is measured using a 0 to 10 points pain scale at D0 and M1 after injection 7. Safety is measured using Injection Site Reactions (ISR) rated by a live assessor and by the subjects and by the collection of adverse events after treatment, at M1, M3, M6 and M9 | — |
Countries
France
Outcome results
None listed