ISRCTN20356582已完成未知
Clinical study for the safety and effectiveness of the use of Perfectha® Derm lidocaine in the treatment of medium lines and depressions
Sinclair Pharma0 个研究点目标入组 70 人开始时间: 2022年11月9日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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 a hyaluronic acid filler product
- •4. Subject presenting mild to medium lines and depressions such as:
- •4.1. Mild to moderate NLFs (score 2 or 3 on both sides of the face [identical score on both sides required] on the Wrinkle Severity Rating Scale [WSRS]) as assessed live by the independent investigator
- •4.2. Shallow to moderate marionette lines (score 1 or 2 on both sides of the face [identical score on both sides required] on the Marionette Lines Grading Scale [MLGS]) as assessed live by the independent investigator
- •5. The extent(s) of the subject’s nasolabial folds or marionette lines is/are sufficient that it is possible to achieve at least a 1-point improvement on the WSRS or MLGS scale with study intervention based on the judgement of the live independent investigator
- •6. Subject having given freely and expressly his/her informed consent and data privacy consent
- •7. Subject affiliated with a health social security system
- •8. Subject willing to have photographs of the face taken and who are willing to provide approval for the use of their study data and anonymized photographs in published literature
- •9. Subject willing and able to comply with study follow-up procedures and schedule
- •10. Females of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during the study.
- •11. Subjects willing to commit to having no further facial aesthetic treatments for the duration of the study period, including follow-up:
- •11.1. For the subjects treated in NLF, no treatment in the mid-face/cheeks and nose area
- •11.2. For the subjects treated in ML: no treatment on the lips or nose
排除标准
- •1. Pregnant or nursing woman or planning a pregnancy during the study
- •2. Subject who has 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 is an employee of the investigational site, the CRO or the study sponsor
- •5. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make-up)
- •6. Subject with major dental problems or major dental procedure within 6 weeks before screening visit or planned during the study
- •7. Subject under epidemiologic surveillance or in quarantine linked to the COVID-19 pandemic
- •8. 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
- •9. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
- •10. Subject with uncontrolled epilepsy
- •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 (recurrent herpes, acne, rosacea) on or around the mouth within 6 months of the study entry
- •14. Subject predisposed to keloids or hypertrophic scarring
- •15. Subject with known bleeding/clotting disorder or is receiving medication that will likely increase the risk of bleeding during treatment (taking thrombolytics, anticoagulants, aspirin, non-steroidal anti-inflammatory drugs or vitamin C) during 10 days before each injection
- •16. Subject with a known history of precancerous lesions/skin malignancies on the face
- •17. Subject with hypersensitivity or with known allergy to hyaluronic acid, lidocaine, amide-type local anaesthetics, avian proteins, feathers and egg or to one of the antiseptic solutions (chlorhexidine)
- •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 effectiveness and safety
- •20. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta-blockers)
- •21. Subject having received treatment with a laser or UV, dermabrasion, deep chemical peel, prolonged sun exposure or any other procedure based on active dermal response on/around the treated area within the past 6 months
- •22. Subject having received surgery anywhere on the face within the past 6 months (12 months of washout are required for the cervicofacial lifting and rhinoplasty)
- •23. Subject having received within the past 12 months any hyaluronic acid filler treatment anywhere in the face
- •24. Subject having received within the past 24 months any semi-permanent filler (e.g., CaHA, poly-L-lactic acid) anywhere in the face or having received anytime any botulinum toxin or semi-permanent filler on the treated areas
- •25. Subject having received at any time a fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) on the face
- •26. Subjects with subcutaneous retaining structure on the face (meshing, threads, gold strand etc)
- •27. 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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