Safety and Efficacy Study of Hya-Dermis Mixed With Lidocaine Injection for the Improvement of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain Visual Analog Scale
研究概览
简要总结
This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed, single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan University Hospital Research Ethics Committee. The aim of this post-marketing study is to evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential loss to follow-up, the minimum enrollment was statistically determined to be 40 patients.
The study was estimated to be held one and half year including a 0-2 weeks screening period, a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF) severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets of randomized numbers are used, patient numbers and treatment numbers. Participants with odd patient numbers will be assigned to nasolabial group and those with even patient numbers will be assigned to nasolabial&cheekbone group. Participants receive experiment treatment (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with normal saline) in the other side of the face randomly depending on the treatment numbers. Both physicians and participants are only blind to the treatment assignment. 30 minutes after the injection, a post-photograph will be used to evaluate NLF severity scale scores and global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the Visual Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction will be collected from patients. The effectiveness analyses compare NLF severity scale scores and GAIS based on photograph records from physicians, as well as participant questionnaires for each group on every visit. The safety assessment evaluates any recorded adverse events following the device treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 30 to 60 years of age and of any sex and willing to receive nasolabial folds correction by intradermal injection procedures
- •Have ability to understand and comply with the study requirements
- •Have approximately symmetrical nasolabial folds with a nasolabial folds severity score of 2-3 and the score difference between two sides is less 1
- •Agree to refrain from undergoing other anti-wrinkle treatments in the injective areas 12 months after the injections.
- •If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
- •Be willing to provide written informed consent prior to any procedures
排除标准
- •Have history or active dermal diseases, inflammation, or any related disease, such as infection, psoriasis, and herpes.
- •Have history of coagulation defect diseases and still take aspirin, other anti-clotting, or blood activating medications 1 week before the treatments
- •Had permanent or semi-permanent implantation on nasolabial areas
- •Had dermal-related surgeries history (for example, laser, chemical dermabrasion, fraxel laser, thermocool) 6 months before the treatments.
- •Had facial wrinkles and folds corrections (for example, botox or other dermal fillers) 6 months before the study starts
- •Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
- •Have a known history of allergic reactions to lidocaine other local anesthesia
- •Have poor compliance with the study or follow-up schedule
研究组 & 干预措施
Normal saline
Participants will be randomly assigned to nasolabial or nasolabial&cheekbone group and receive control treatment (20mg/ml hyaluronic acid mixed with 0.175 ml normal saline) in one side of the face.
干预措施: Normal Saline (Drug)
Lidocaine
Participants will be randomly assigned to nasolabial or nasolabial&cheekbone group and receive experiment treatment (20mg/ml hyaluronic acid mixed with 0.175 ml 2% lidocaine) in one side of the face.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain Visual Analog Scale
时间窗: 30 miuntes post-treatment
A quantification of the severity of pain experienced by individuals during the treatments. A scale of 100 mm horizontal line will be labeled by participants to assess pain on both sides of the injected areas 30 minutes after the treatment. The one on the extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by participants.
Adverse events report
时间窗: From date of treatment to 12 months
Any adverse events and abnormal physical parameters or reports occurred and disappeared should be monitored throughout the trial. The records should be assessed and keep on track of the severity of individual adverse events and correlation with the treatment. Severity assessment: To assess the level of severity by rating 0 (none), 1 (mild), 2 (median), and 3 (sever). Correlation assessment: Physicians evaluate the impact of adverse events for each individual and determine their causality of the treatment. Based on the correlation with the treatment, giving score 0 (no correlated), 1 (low correlated), 2 (suspected correlated), 3 (most likely correlated). Adverse events tracking: Any adverse events should be reported to the physicians by participants. Physicians keep following up adverse events experienced participants until the event disappeared or the symptoms stabilized.
次要结局
- Nasolabial folds (NLF) severity scale(From the baseline, 30 minutes post-treatment, to every follow-up at 1, 3, 6, 9, 12 months)
- Aesthetic satisfaction questionnaire(From the baseline, 30 minutes post-treatment, to every follow-up at 1, 3, 6, 9, 12 months)
- Global aesthetic improvement scale (GAIS)(30 minutes post-treatments and follow-ups at 1, 3, 6, 9, 12 months)