Double-blind, Randomized and Controlled Clinical Trial to Compare Safety and Efficacy of a Metallic Cannula vs a Standard Needle for the Injection of Hyaluronic Acid Gel Dermal Filler (Restylane®) to Treat Nasolabial Folds
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of Participants With Haematoma
研究概览
简要总结
The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.
详细描述
This was a monocentric, prospective, randomized, phase II and double-blind study.
At the baseline visits, one investigator rated the severity of nasolabial folds on both left and right sides according to the mentioned scale, and a standard set of six photographs of the face (frontal, left side and right side for both the whole face and the lower face) were taken.
On the day of the injection, the main investigator injected 1ml of dermal filler - hyaluronic acid (Restylane®, Q-Med, Uppsala, Sweden) - for each subject. The injected amount was 0,5ml for the right nasolabial fold and 0,5ml for the left nasolabial fold. The sides will be randomized.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
- •Female subjects aged from 18 to 60
- •Fitzpatrick phototype I to VI
- •Presence of bilateral folds graded from 2 to 3 according to the Modified
- •Fitzpatrick Wrinkle Scale
- •Subjects that have never performed any treatment of nasolabial folds
- •Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method
- •Subjects who will be available throughout the duration of the study
- •Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.
排除标准
- •Use of systemic corticosteroids
- •History of herpes in lip
- •Inflammation or active infection in the area to be injected
- •Any surgical treatment or cosmetic procedure in the area to be injected that interfere in study's outcomes
- •Coagulation disorders or use of anticoagulants
- •Previous hypersensitivity responses to Hyaluronic acid.
- •Pregnant or women in breastfeeding, or women planning to become pregnant
研究组 & 干预措施
Metallic cannula
Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool
干预措施: Hyaluronic acid injected with the new tool. (Drug)
Metallic cannula
Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool
干预措施: hyaluronic acid with metallic cannula or standard needle. (Procedure)
Standard needle
Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle.
干预措施: hyaluronic acid with metallic cannula or standard needle. (Procedure)
结局指标
主要结局
Number of Participants With Haematoma
时间窗: Day 1; day 3; day 7; day 90
Number of participants with haematoma at each visit
Number of Participants With Erythema
时间窗: Day 1; day 3; day 7; day 90
Number of participants with erythema at each visit
次要结局
- Modified Fitzpatrick Wrinkle Scale (MFWS)(Baseline and 90 days)
- Global Aesthetic Improvement Scale(90 days)
研究者
Doris Hexsel
MD
Brazilan Center for Studies in Dermatology