ISRCTN49836437进行中（未招募）4 期
Safety and effectiveness clinical evaluation of the range of Kysense® injectable medical devices in facial aesthetic treatment
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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