NCT06093321Unknown不适用
A Randomized, Blinded, Active-Controlled, Matched Pairs, Single-Institution, Non-Inferiority Trial to Compare and Evaluate the Efficacy and Safety of SYB PDO Thread and MINT Lift® for Temporarily Improvement of Nasolabial Folds
Samyang Biopharmaceuticals Corporation2 个研究点 分布在 2 个国家目标入组 55 人开始时间: 2023年11月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application.
研究概览
简要总结
The objective of this clinical trial is to verify the safety and efficacy of SYB PDO Thread in the temporary improvement of nasolabial Folds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those desiring temporary improvement of central facial nasolabial folds and having a Wrinkle Severity Rating Scale (WSRS) score of 3 or
- •Individuals willing to discontinue all dermatological procedures or treatments, including wrinkle improvement in the central facial nasolabial fold, throughout the duration of this clinical trial.
排除标准
- •Individuals who need to take anticoagulants from 2 weeks before the application of the clinical trial medical device to 2 weeks after (low-dose aspirin 100mg, maximum 300mg/day, is allowed).
- •Those who need to take Vitamin E supplements, NSAIDs, or collagen supplements from 1 week before the application of the clinical trial medical device to 1 week after.
- •Individuals with a history of bleeding disorders, either past or present.
- •Those who have received treatments such as deep chemical peels, skin rejuvenation procedures, plastic surgery (including Botox injections), wrinkle improvement, or acne scar treatment on the face within 24 weeks from the screening date.
结局指标
主要结局
The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application.
时间窗: 3months
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial FoldsNasolabial FoldsNCT03932045Samyang Biopharmaceuticals Corporation59
已完成
1 期
Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated VasculitisANCA-associated VasculitisNCT05197842Staidson (Beijing) Biopharmaceuticals Co., Ltd93
已完成
2 期
Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for ColonoscopyColonoscopy PreparationNCT02123017Cumberland Pharmaceuticals32
已完成
1 期
A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With ObesityHealthyNCT05712876Cytoki Pharma76
已完成
3 期
Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)RhinoconjunctivitisAllergyNCT00537342Laboratorios Leti, S.L.83