NCT04486794已完成不适用
A Clinical Evaluation of the Efficacy and Safety of Hyaluronic Acid (Restylane®) for the Treatment of Tear Trough Deformity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- GAIS
研究概览
简要总结
The aim of this study is to investigate the effectiveness and tolerability of Restylane® for correction of tear trough deformity, using various injection techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of 18 years or greater;
- •Indication for treatment of bilateral tear trough deformity;
- •Symmetry of tear trough deformity at baseline;
- •Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure.
排除标准
- •Prior (<1 year) or planning to undergo any surgery in the corporal area of interest for study;
- •Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments;
- •Diabetes mellitus type 1 or type 2;
- •Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
- •Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
- •Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
- •Pregnant or breastfeeding, or wishes to get pregnant within the next 12 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential);
- •Restylane® should not be used in any person who has hypersensitivity to any of the components of the product;
- •Active skin inflammation or infection in or near the treatment area;
- •Possessing any of the contraindications for use of Restylane®;
- •Septal fat herniation;
- •Severe elastosis (e.g., dermatochalasis);
- •Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) within 1 week of treatment.
- •Use of tear trough injections in the last 12 months.
- •Use of anterior midface injections in the last 12 months.
结局指标
主要结局
GAIS
时间窗: 1 month
Improvement via the blinded evaluator-assessed Global Aesthetic Improvement Scale (GAIS), at the one-month follow up visit. Improvement will be considered as any point-increase above 0 (no change).
次要结局
- Adverse events(Baseline to end of study (up to week 10))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne ScarsHealthy VolunteersNCT03127384Galderma R&D49
已完成
不适用
Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial FoldsNasolabial Folds in Chinese PopulationNCT02432742Galderma R&D100
已完成
不适用
Study to Evaluate Restylane Vital Light Using an Injector DeviceAestheticsNCT01412190Galderma R&D30
已完成
不适用
Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye DiseaseDry Eye DiseaseNCT03492541Alcon Research134
已完成
不适用
Restylane Perlane to Shape the Nasal Dorsum and/or Nasal RootNasal AugmentationNCT02216851Galderma R&D132