ISRCTN33480483进行中（未招募）4 期
A prospective, single-center, clinical study to evaluate the efficacy and safety of silhouette soft suture as a treatment of nasolabial folds and jowl laxity
Sinclair Pharma0 个研究点目标入组 24 人开始时间: 2022年1月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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. Healthy subject
- •2. Sex: male or female
- •3. Age: between 35 and 50 years
- •4. Subject with a BMI comprised between 18.5 and 30 kg/m²
- •5. Subject with no ongoing or planned diet
- •6. Subject with moderate to severe nasolabial folds as determined by a WSRS score of 3 to 4 in both folds (balanced ratio)
- •7. Subject with a mild to moderate skin laxity as determined by an FLR score of 3 to 6 on both sides of the face
- •8. Subject with dense and not too thin skin
- •9. Subject seeking for an improvement of their wrinkle’s severity and skin quality on the mid-face by an aesthetic procedure
- •10. Subject having given freely and expressly his/her informed consent
- •11. Subject willing and able to comply with study follow-up procedures and schedule
- •12. Subject affiliated to a health social security system
- •13. Females of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before the beginning of the study and during all the study
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 having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study
- •6. Subject enrolled in another clinical trial or which exclusion period is not over
- •7. Subject suffering from a serious or progressive disease, which, in the investigator’s judgment, puts the subject at undue risk (e.g. diabetes, autoimmune pathology, cardiac pathologies (Coronary heart failure, ventricular rhythm disturbances, severe hypertension, obstructive cardiomyopathy), hyperthyroidism, hepatic deficiency, epilepsy, porphyria)
- •8. Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events
- •9. Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder
- •10. Subject has a history of precancerous lesions/skin malignancies
- •11. Subject with active skin disease within 6 months of study entry
- •12. Subject with scars, rosacea, herpes, acne, blotches or other pathology in the mid-face, at the investigator appreciation
- •13. Subject predisposed to keloidosis or hypertrophic scarring
- •14. Subject with known history of hyper- or hypo-pigmentation in the mid-face
- •15. Subject has a known history of multiple allergies, allergic/anaphylactic reactions including hypersensitivity to lidocaine, anaesthetics of the amide type, sulfites or the used antiseptic components (chlorhexidine and quaternary ammonium), to the antibiotics of tetracycline family or to lanoline or wool fat
- •16. Subject has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment
- •17. Subject with extensive skin laxity, thin skin and/or severe malar fat sagging
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