Safety and effectiveness clinical evaluation of the range of injectable hyaluronic acid medical devices in facial aesthetic treatment
- Conditions
- Moderate to severe peri-oral lines, moderate to severe nasolabial folds, moderate to severe cheeks/cheekbones volume deficit, chin recursionSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN49836437
- Lead Sponsor
- Kylane Laboratoires SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 68
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method