ISRCTN30768206进行中（未招募）未知
Clinical study of the safety and effectiveness of the use of MaiLi Precise® and MaiLi Define® in the treatment of lips and perioral area
Sinclair Pharma0 个研究点目标入组 68 人开始时间: 2022年3月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 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
- Observational
入排标准
- 性别
- All
入选标准
- •1. Sex: female or male
- •2. Age: between 18 and 65 years
- •3. Subject seeking an improvement of her/his lip volume and/or perioral area
- •4.1. For group 1: subject with very thin to thin lips volume (score 1 to 2 on Rossi scale) and /or subject with moderate to severe perioral wrinkles (score 2 to 6 on the Bazin scale)
- •4.2. For group 2: subject with thin to moderate lips volume (score 2 to 3 on Rossi scale)
- •5. Subject having given freely and expressly his/her informed consent
- •6. Subject willing to have photographs of the face taken and who are willing provide approval for the use of their study data and photographs in published literature
- •7. Subject willing and able to comply with study follow-up procedures and schedule
- •8. Subject affiliated to a health social security system
- •9. Females of childbearing potential should use a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and during the study
- •10. Subject willing to commit to having no further facial aesthetic treatments below the zygomatic arch for the duration of the study period, including follow-up
排除标准
- •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 is an employee of the investigational site, the CRO or the study sponsor
- •6. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make-up)
- •7. Subject with major dental problems
- •8. Subject under epidemiologic surveillance / in quarantine linked to the COVID-19 pandemic
- •9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety
- •10. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
- •11. Subject with porphyria
- •12. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
- •13. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea) on or around the lips within 6 months of the study entry
- •14. Subject predisposed to keloids or hypertrophic scarring
- •15. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment
- •16. Subject with a known history of precancerous lesions/skin malignancies
- •17. Subject with hypersensitivity or with known allergy to: hyaluronic acid, lidocaine, amide-type local anaesthetics or to one of the components of the tested devices or antiseptic solution
- •18. Subject with a known history of severe allergy or anaphylactic shock
- •19. Subject having received any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of efficacy and safety
- •20. Subject having received treatment with a laser or UV, dermabrasion, surgery, deep chemical peeling or any other procedure based on active dermal response on/around the lips within the past 6 months
- •21. Subject received within the past 12 months hyaluronic acid injections (not including this study) on or around the lips
- •22. Subject received at any time permanent filler (e.g. polylactic acid, PMMA, silicone) on or around the lips
- •23. Subject received at any time a lip threading surgery
- •24. Subject received oral surgery (e.g. tooth extraction, orthodontia or implantation) within 6 weeks prior to study entry
- •25. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment
- •26. Subject having started or changed his/her oral contraceptive or any other hormonal treatment during 12 weeks prior to study entry
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