Moderate to severe peri-oral lines, moderate to severe nasolabial folds, moderate to severe cheeks/cheekbones volume deficit, chin recursion Skin and Connective Tissue Diseases
Conditions
Interventions
The objective of the study is to collect post-marketing data on the safety and effectiveness of the Kysense® range used on different facial injection sites. Four subgroups will be included in this stu
Sponsors
Kylane Laboratoires SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject seeking an improvement of her/his face aspect with HA filler 2. For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) 3. For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on WSRS scale) 4. For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale) 5. For group 4: Subject seeking improvement of chin retrusion 6. Subject with a stable weight since the last 6 months and who agree to keep a stable weight during the study 7. Subject, having given freely and expressly his/her informed consent 8. Subject psychologically able to understand the study-related information and to give a written informed consent 9. Subject affiliated to a health social security system 10. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks and during all the study
Exclusion criteria
Exclusion criteria: In terms of population: 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 research involving human beings in the 12 previous months, including participation in the present study 6. Subject enrolled in another study or which exclusion period is not over 7. Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up) In terms of associated pathology: 8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety 9. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency 10. Subject suffering from an active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria) in the 6 months before the screening visit. Subjects with a history of herpes are not eligible even if asymptomatic at the time of inclusion 11. Subject with a history of streptococcal disease or an active streptococcus infection 12. Subject prone to develop inflammatory skin conditions or having a tendency to bleeding disorders 13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders 14. Subject with a history of severe allergy or anaphylactic shock including known hypersensitivity to one of the ingredients of the investigational device (i.e. hyaluronic acid), to antiseptic solution or to amide-type anaesthetics Relating to previous or ongoing treatment: 15. Any medication which may interfere, at the interpretation of the investigator, with the study objectives 16. Subject having received treatment with a laser, dermabrasion, surgery, chemical peeling or any other procedure based on active dermal response on the face within the past 6 months or who plans to undergo any of these procedures during the study 17. Subject having received within the past 18 months or planning to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., hyaluronic acid, CaHA) or neurotoxin on or near the treated zone 18. Subject having received at any time or plans to receive during the study a permanent filler (e.g., polylactic acid, PMMA, silicone) on the face 19. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand) 20. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit or being a chronic user 21. Subject undergoing a topical treatment on the test area or a systemic treatment: 21.1. Anti-inflammatory medication and/or antih
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of the Kysense® range used on different treated zones assessed using a clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent assessor at 1 month (T1) after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effectiveness of the Kysense® range used on different treated zones assessed using a clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent assessor at 6 months (T6), 12 months (T12) and 18 months (T18) 2. Safety assessed using clinical evaluation of the Injection Site Reactions (ISR) rated by the subject and the assessor, and by the collection of adverse events at T1, T6, T12 month + T18 month for a part of the population (groups 3 & 4) 3. Subject’s satisfaction and subject’s opinion on aesthetic improvement on the different treated zones using clinical evaluation of the global aesthetic improvement (GAIS) at T1, T6, T12 month + T18 months for a part of the population (groups 3 & 4) 4. The injector's satisfaction with the injection quality measured using a subjective evaluation questionnaire at the injection visit 5. Device effectiveness assessed using face macrophotographs at the injection visit, 1 month, 6 months, 12 months and 18 months if applicable | — |
Countries
France
Outcome results
None listed