NCT06380972Unknown不适用
A Prospective, Multicenter, Randomized, No-treatmentcontrolled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour
AQTIS Medical B.V.2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)
研究概览
简要总结
A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour
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
- Single (Outcomes Assessor)
盲法说明
the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age (whichever is the time of signing informed consent) of either sex;
- •Subjects who are seeking treatment for forehead contour improvement;
- •Subjects with moderate to severe forehead contour deficiency (i.e., ASFS score of 2-3) as evaluated by blinded investigator according to Asian Sloping Forehead Scale (ASFS);
- •Subjects who are in good health and suitable for receiving treatment for forehead contour improvement as assessed by the investigator;
- •Subjects who are willing to sign informed consent, understand and accept the duration of the study, and are able and willing to comply with all requirements, including scheduled treatment, follow-up, and other study procedures (including clinical photography).
排除标准
- •Those with a history of severe allergy or anaphylactic shock or those with a history of allergy which may result in a response to treatment;
- •Those with known allergy to polycaprolactone, carboxymethylcellulose, or any of the ingredients in this product, any local anesthetics such as lidocaine or other amide anesthetics;
- •Those with tattoos, scars, deformities, non-healing wounds, active skin disease or skin inflammation (e.g., herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, etc.), abscess, cancer or pre-cancerous lesions and so forth on the forehead that may affect the evaluation of efficacy or increase the risk of treatment;
- •Those who have received, or plan to receive during the trial, any permanent filler (e.g., polymethyl methacrylate, organic silicon, expanded polytetrafluoroethylene, etc.), autologous fat or unspecified injectables in the frontal region;
- •Those who have received treatment on the forehead such as calcium hydroxyapatite (CaHA), poly-L-lactic acid (PLLA), and polycaprolactone (PCL) within 2 years prior to screening or during the planned trial;
研究组 & 干预措施
no treatment control
No Intervention
Polycaprolactone (PCL) Based Facial Injectable
Experimental
干预措施: Polycaprolactone (PCL) Based Facial Injectable (Device)
结局指标
主要结局
The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)
时间窗: Month 12
次要结局
- The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS)(at Months 1, 3, 6, 9 and 12)
- The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS)(at Months 1, 3, 6, 9 and 12)
- The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS)(at Months 1, 3, 6 and 9)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
A Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour DeficitJawline Contour DeficitNCT06391580Sinclair Pharmaceuticals Limited192
招募中
不适用
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese AdultsInfraorbital HollowsNCT06749587Teoxane SA260
招募中
Unknown
A superiority, confirmatory clinical trial to assess the efficacy of cognitive therapy software ‘NDTx-01’ in patients with autism spectrum disorder (ASD) or social communication disorders (SCD)Mental and behavioural disordersKCT0009699eudive Inc.80
进行中（未招募）
不适用
A prospective, multicenter, randomized, rater- and subject-blind, parallel group trial to investigate the non-inferiority of NT 201, free of complexing proteins, in comparison with Clostridium botulinum toxin type A in the treatment of glabellar frown line - NT-H2HTreatment of glabellar frown linesMedDRA version: 10.1Level: LLTClassification code 10052609Term: <Manually entered code. Term in E.1.1>EUCTR2008-002713-40-GBMerz Pharmaceuticals GmbH384
进行中（未招募）
不适用
A prospective, multicenter, randomized, rater- and subject-blind, parallel group trial to investigate the non-inferiority of NT 201, free of complexing proteins, in comparison with Clostridium botulinum toxin type A in the treatment of glabellar frown line - NT-H2HTreatment of glabellar frown linesMedDRA version: 10.1Level: LLTClassification code 10052609Term: <Manually entered code. Term in E.1.1>EUCTR2008-002713-40-DEMerz Pharmaceuticals GmbH384