ISRCTN13586698进行中（未招募）Unknown
Assessment of the safety and effectiveness of the use of HYDRAGEL C in the treatment of the periorbital and nasolabial fold wrinkles, cheeks and cheekbones
ouna Aesthetics0 个研究点目标入组 75 人开始时间: 2023年8月21日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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. Healthy subject
- •2. Sex: male or female
- •3. Age: between 18 and 70 years
- •4. Subject seeking an improvement of her/his face aspect with HA filler
- •*For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) and lips contour requiring redefinition
- •*For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on the WSRS scale) and/or seeking an improvement of lip volume (score 1 or 2 for superior and/or inferior lip on the Rossi scale)
- •*For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale)
- •5. Subject with a stable weight for the last 6 months and who agrees to keep a stable weight during the study
- •6. Subject having given her/his free, express, and informed consent
- •7. Subject psychologically able to understand the information related to the study, and to give their written informed consent
- •8. Subject registered with a social security scheme
- •9. Women of childbearing potential should use a contraceptive method considered effective for at least 12 weeks and throughout the study
排除标准
- •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 a total of 6000 euros as compensation for her/his participation in clinical research in the last 12 months, including their participation in the present study
- •6. Subject enrolled in another study or whose non-enrollment 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)
- •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 known history of or suffering from autoimmune disease and/or immune deficiency
- •10. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, severe acne, severe rosacea, porphyria) in the 6 months before screening visit
- •11. Subject with a history of streptococcal disease or an active streptococcus infection
- •12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
- •13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders
- •14. Subject having a history of severe allergy or anaphylactic shock including known hypersensitivity to one of the ingredients of the investigational device (i.e. HA), seafood, to antiseptic solution (Diaseptyl®) or to lidocaine amide-type anaesthetics (EMLA®), related to previous or current treatments
- •Previous or ongoing treatment:
- •15. Subject having received a dose of COVID-19 vaccine within the 14 days prior to injection or planning to receive a dose in the 3 weeks following injection
- •16. Any medication which may interfere, at the interpretation of the investigator, with the study objectives
- •17. Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, surgery, a 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
- •18. 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., HA, Calcium Hydroxyapatite) or autologous fat on or near the treated zone
- •19. Subject having received within the past 9 months or planning to receive during the study any injections outside of those in the study protocol including mesotherapy or botulinum neurotoxin on or near the treated zone
- •20. Subject having received at any time or planning to receive a permanent filler on the face (e.g., polylactic acid, Polymethylmethacrylate, silicone) during the study.
- •21. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand)
- •22. 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
- •23. Subject undergoing a topical treatment on the test area or a systemic treatment:
- •23.1. Anti-inflammatory medication a
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