ISRCTN72858148进行中（未招募）未知
Assessment of the safety and effectiveness of the use of Perfectha® Derm Lidocaine and Perfectha® Deep Lidocaine in the treatment of lips
Sinclair Pharma0 个研究点目标入组 68 人开始时间: 2022年11月17日最近更新:
适应症
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
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Sex: female or male
- •2. Age: between 18 and 65 years
- •3.1. For group 1: subject seeking treatment for lip volume and for lip contour redefinition
- •3.2. For group 2: subject seeking treatment for lip volume
- •4.1. For group 1: subject with very thin to thin lip volume (grade 1 to 2 for superior and/or inferior lip on the Rossi scale) and with lip contour somewhat well-defined to poorly defined (grade 2 or 3 on the Draelos vermilion border scale)
- •4.2. For group 2: subject with thin to moderate lip volume (grade 2 to 3 for superior and/or inferior lip on the Rossi scale)
- •5. Subject having given freely and expressly his/her informed consent and data privacy consent
- •6. 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
- •7. Subject willing and able to comply with study follow-up procedures and schedule
- •8. Subject affiliated with a health social security system
- •9. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during the study
- •10. Subject willing to commit to having no further facial aesthetic treatments on the nose, lips, perioral lines and marionette lines 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 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 not eligible for scientific reasons at the interpretation of the investigator
- •8. Subject under epidemiologic surveillance/in quarantine linked to the COVID-19 pandemic
- •9. Subject having a medical history which may interfere, at the interpretation of the investigator, with the study objectives in terms of effectiveness and safety
- •10. 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
- •11. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
- •12. Subject with uncontrolled epilepsy
- •13. Subject with porphyria
- •14. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
- •15. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (recurrent herpes, acne, rosacea) on or around the lips within 6 months of the study entry
- •16. Subject predisposed to keloids or hypertrophic scarring
- •17. 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
- •18. Subject with a known history of precancerous lesions/skin malignancies on/around the lips
- •19. Subject with hypersensitivity or with known allergy to hyaluronic acid, lidocaine, local disinfectant containing quaternary ammonium salts, amide-type local anaesthetics, avian proteins, feathers and egg or to one of the antiseptic solution
- •20. Subject with a known history of severe allergy or anaphylactic shock
- •21. Subject having received any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of effectiveness and safety
- •22. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta-blockers)
- •23. 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 lips within the past 6 months
- •24. Subject having received surgery anywhere on the face within the past 6 months (12 months of washout are required for the cervicofacial lifting)
- •25. Subject having received within the past 12 months any hyaluronic acid filler
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