For MaiLi Precise® treatment: very thin to thin lip volume and /or moderate to severe perioral wrinkles
Conditions
Interventions
34 subjects will be included in group 1 and treated with MaiLi Precise®:
1. At least 12 will be treated for lip volume
2. At least 11 will be treated for lip definition
3. At least 11 will be treated
Sponsors
Sinclair Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sex: female or male 2. Age: between 18 and 65 years 3. Subject seeking an improvement of her/his lip volume and/or perioral area 4.1. For group 1: subject with very thin to thin lips volume (score 1 to 2 on Rossi scale) and /or subject with moderate to severe perioral wrinkles (score 2 to 6 on the Bazin scale) 4.2. For group 2: subject with thin to moderate lips volume (score 2 to 3 on Rossi scale) 5. Subject having given freely and expressly his/her informed consent 6. Subject willing to have photographs of the face taken and who are willing provide approval for the use of their study data and 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. Females of childbearing potential should use a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and during the study 10. Subject willing to commit to having no further facial aesthetic treatments below the zygomatic arch 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 suspected to be non-compliant according to the investigator’s judgment 5. Subject is an employee of the investigational site, the CRO or the study sponsor 6. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make-up) 7. Subject with major dental problems 8. Subject under epidemiologic surveillance / in quarantine linked to the COVID-19 pandemic 9. 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 10. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency 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 (herpes, acne, rosacea) on or around the lips within 6 months of the study entry 14. Subject predisposed to keloids or hypertrophic scarring 15. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment 16. Subject with a known history of precancerous lesions/skin malignancies 17. Subject with hypersensitivity or with known allergy to: hyaluronic acid, lidocaine, amide-type local anaesthetics or to one of the components of the tested devices or antiseptic solution 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 efficacy and safety 20. Subject having received treatment with a laser or UV, dermabrasion, surgery, deep chemical peeling or any other procedure based on active dermal response on/around the lips within the past 6 months 21. Subject received within the past 12 months hyaluronic acid injections (not including this study) on or around the lips 22. Subject received at any time permanent filler (e.g. polylactic acid, PMMA, silicone) on or around the lips 23. Subject received at any time a lip threading surgery 24. Subject received oral surgery (e.g. tooth extraction, orthodontia or implantation) within 6 weeks prior to study entry 25. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment 26. 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 measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by an independent live assessor 6 months after treatment (M6) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Aesthetic improvement measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by a live assessor 1 month (M1) and 12 months (M12) after treatment 2. Aesthetic improvement measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjects at M1, M6 and M12 3. Subject's satisfaction measured using an in-house questionnaire at M1, M6 and M12 4. Injector satisfaction measured using an in-house questionnaire at M1 5. Improvement of treated areas measured using Rossi and Bazin scales evaluated by an assessor on photographs at M1, M6 and M12 6. Safety 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, M6 and M12 | — |
Countries
France
Outcome results
None listed