ISRCTN10761529已完成未知
Clinical study of the safety and effectiveness of MaiLi Precise® and MaiLi Define® in the treatment of facial skin depressions
Sinclair Pharma0 个研究点目标入组 68 人开始时间: 2022年2月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Sex: female or male
- •2. Age: between 25 and 65 years
- •3. Subject seeking an improvement of her/his face aspect with hyaluronic acid filler product
- •4.1. For group 1: subject with mild to moderate nasolabial folds (score 2 to 3 on the Wrinkle Severity Rating Scale [WSRS]) and/or subjects with mild to moderate tear trough (score 1 to 2 on the Barton scale)
- •4.2. For group 2: subject with moderate to severe nasolabial folds (score 3 to 4 on the WSRS scale) and/or subjects with moderate to severe marionette lines (score 2 and 3 on the Marionette Lines Grading Scale (MLGS)
- •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. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during all the study
- •9. Subjects willing to commit to having no further facial aesthetic treatments below the level of the eyes 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 in a social or sanitary establishment
- •3. Subject suspected to be non-compliant according to the investigator’s judgment
- •4. Subject is an employee of the investigational site, the CRO or study sponsor
- •5. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation
- •6. 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
- •7. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
- •8. Subject with porphyria
- •9. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
- •10. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea) on the face within 6 months of the study entry
- •11. Subject predisposed to keloids or hypertrophic scarring
- •12. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment
- •13. Subject with a known history of precancerous lesions/skin malignancies
- •14. 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
- •15. Subject with a known history of severe allergy or anaphylactic shock
- •16. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety
- •17. Subject having received treatment with a laser or UV, dermabrasion, surgery, deep chemical peeling or any other procedure based on active dermal below the level of the eyes within the past 6 months
- •18. Subject having received within the past 12 months hyaluronic acid injections (not including this study) below the level of the eyes
- •19. Subject having received at any time permanent filler (e.g. polylactic acid, PMMA, silicone) below the level of the eyes
- •20. Subject having received at any time threading surgery
- •21. 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
- •22. 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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