ISRCTN16392182进行中（未招募）未知
Assessment of the safety and effectiveness of use of Perfectha® Finelines Lidocaine in the treatment of the periorbital and perioral wrinkles and tear troughs
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 69
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. Subject with mild to moderate tear troughs (score 1 to 2 on the Barton scale) and/or Subject with moderate to severe perioral wrinkles (score 2 to 6 on the upper lip wrinkles Bazin scale). and/or Subject with shallow to deep crow’s feet wrinkles, also known as periorbital wrinkles (score 2 to 4 on the Lemperle periorbital lines 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 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 to 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 all the study.
- •10. Subject willing to commit to having no further facial aesthetic treatments for the duration of the study period, including followup:
- •10.1. For the subjects treated in tear troughs, no treatment in the mid-face, tear troughs, periorbital lines below the eyes and nose area.
- •10.2. For the subjects treated in perioral wrinkles, no treatment in the nose, lips and perioral area.
- •10.3. For the subjects treated in periorbital wrinkles, no treatment in the periorbital, temples and nose area
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 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. For subjects treated in perioral wrinkles: subject with major dental problems or major dental procedure withing 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 term 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 known history of or suffering from autoimmune disease and/or immune deficiency.
- •12. Subject with uncontrolled epilepsy.
- •13. Subject with porphyria.
- •14. Subject with 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 eyes and 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, nonsteroidal anti-inflammatory drugs or vitamin C) during 10 days before each injection.
- •18. Subject with known history of precancerous lesions/skin malignancies on/around the eyes and 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 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 term 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 eyes and lips within the past 6 months.
- •24. Subject having received a surgery anywhere on the face within the past 6 months (12 months of washout are required for the cervicofacial lifting and rhin
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