Moderate to severe nasolabial folds severity and mild to moderate skin laxity Skin and Connective Tissue Diseases
Conditions
Interventions
24 subjects will be included in total and treated with Silhouette Soft® (SMS 22, SMS 23 and SMS 26). The number of sutures to be implanted depends on the naslabial fold severity. Sutures are implanted
Sponsors
Sinclair Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subject 2. Sex: male or female 3. Age: between 35 and 50 years 4. Subject with a BMI comprised between 18.5 and 30 kg/m² 5. Subject with no ongoing or planned diet 6. Subject with moderate to severe nasolabial folds as determined by a WSRS score of 3 to 4 in both folds (balanced ratio) 7. Subject with a mild to moderate skin laxity as determined by an FLR score of 3 to 6 on both sides of the face 8. Subject with dense and not too thin skin 9. Subject seeking for an improvement of their wrinkle’s severity and skin quality on the mid-face by an aesthetic procedure 10. Subject having given freely and expressly his/her informed consent 11. Subject willing and able to comply with study follow-up procedures and schedule 12. Subject affiliated to a health social security system 13. Females of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before the beginning of the study and during all the study
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 having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study 6. Subject enrolled in another clinical trial or which exclusion period is not over 7. Subject suffering from a serious or progressive disease, which, in the investigator’s judgment, puts the subject at undue risk (e.g. diabetes, autoimmune pathology, cardiac pathologies (Coronary heart failure, ventricular rhythm disturbances, severe hypertension, obstructive cardiomyopathy), hyperthyroidism, hepatic deficiency, epilepsy, porphyria) 8. Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events 9. Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder 10. Subject has a history of precancerous lesions/skin malignancies 11. Subject with active skin disease within 6 months of study entry 12. Subject with scars, rosacea, herpes, acne, blotches or other pathology in the mid-face, at the investigator appreciation 13. Subject predisposed to keloidosis or hypertrophic scarring 14. Subject with known history of hyper- or hypo-pigmentation in the mid-face 15. Subject has a known history of multiple allergies, allergic/anaphylactic reactions including hypersensitivity to lidocaine, anaesthetics of the amide type, sulfites or the used antiseptic components (chlorhexidine and quaternary ammonium), to the antibiotics of tetracycline family or to lanoline or wool fat 16. Subject has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment 17. Subject with extensive skin laxity, thin skin and/or severe malar fat sagging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasolabial folds severity is measured using the Wrinkles Severity Rating Scale (WSRS) by a live evaluator, 9 months after implantation of the device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nasolabial folds severity is measured using the Wrinkles Severity Rating Scale (WSRS) by a live evaluator 4, 12 and 18 months after implantation of the device 2. Jawline laxity is measured using the Facial Laxity Rating (FLR) scale by a live evaluator 4, 9, 12 and 18 months after implantation of the device 3. Nasolabial folds severity is measured using Wrinkles Severity Rating Scale (WSRS) by an independent evaluator on photographs 4, 9, 12 and 18 months after implantation of the device 4. Jawline laxity is measured using the Facial Laxity Rating (FLR) scale by an independent evaluator on photographs 4, 9, 12 and 18 months after implantation of the device 5. Nasolabial folds depth and volume are measured using Facial Laxity Rating (FLR) scalefringe projection system (Dermatop) 4, 9, 12 and 18 months after implantation of the device 6. Skin quality is measured using Dermascan, Cutometer and Dermatop 4, 9, 12 and 18 months after implantation of the device 7. Skin collagenesis is measured by analysis of biopsies taken at the level of the suture samples implanted under the chin 4, 9, 12 and 18 months after implantation of the device 8. Global aesthetic measurement is measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjets 4, 9, 12 and 18 months after implantation of the device 9. Physician satisfaction is measured using a questionnaire completed after device implantation on D0 10. Subjects satisfaction is measured using a questionnaire 4, 9, 12 and 18 months after implantation of the device 11. Safety is measured using a cutaneous reaction scale rated by a live evaluator and by the subjects and by the collection of adverse events until 18 months after implantation of the device | — |
Countries
France
Outcome results
None listed