A Multicenter, Prospective, Double-Blinded, Randomized, Parallel-Group, Dose-Ranging Study of Botulinum Toxin Type A Treatment of Wrinkles in Asian
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 主要终点
- The change of wrinkle serenity rating scale after 2 weeks
研究概览
简要总结
OBJECTIVES: The aim of this randomized, parallel-group, double-blinded controlled multicenter clinical trial is to determine the proper dosage of botulinum toxin type A in Asian, and provide evidence-based proof.
METHODS: 250 patients were included in this study, first, trained observers assessed their wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale before injecting botulinum toxin type A, then we injected different dosages to patients with the different pre-injection scores. All patients were followed up for up to one year. Logistic regression was built, the chi-square test was performed, and R square and p-value are used for evaluation.
详细描述
This was a self-reported, randomized, parallel-group, double-blinded controlled multicenter clinical trial. It was conducted in Wuhan, Shanghai, and Dongguan, China, at the plastic and reconstructive surgery, and approved by the ethics committee of Shanghai Ninth People's Hospital, affiliated to Shanghai Jiao Tong University School of Medicine. All patients were fully informed about the study in accordance with the applicable regulations and International Conference on Harmonisation Good Clinical Practices guidelines and gave written informed consent before the study. The main inclusion criteria were: 1. Chinese males or females aged over 18 years old who want to accept medical removal of the wrinkle; 2. noticeable symmetrical wrinkles on both sides of the face (grade 1-4 on the 5-grade Wrinkles Severity Rating Scale); 3. female patients must take a pregnancy test to prove they are not pregnant, and they are also asked to use a method of contraception 30 days before inclusion into the group and to use a reliable method of contraception throughout the entire study; 4. patients should not accept other forms of cosmetic intervention and agree to refrain from participation in any other clinical trials that may interrupt the study. The main exclusion criteria were: 1. the wrinkle severity of any site or both sites are either grade 0 or 5 on the 5-grade Wrinkle Severity Rating Scale. 2. the presence of facial hair that may influence the observation of wrinkle severity; 3. the area of injection had an apparent acne scar, active inflammation, infection, cancer or premalignancy, or untreated wound; 4. patients who had facial plastic surgery, tissue transplant, silica gel, liposome (fat) injection, or other permanent or semi-permanent dermal filler; 5. patients who had any type of Botox injection in the last year or were injected more than 3 times.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese males or females aged over 18 years old who want to accept medical removal of the wrinkle;
- •Noticeable symmetrical wrinkles on both sides of the face (grade 1-4 on the 5-grade Wrinkles Severity Rating Scale);
- •Female patients must take a pregnancy test to prove they are not pregnant, and they are also asked to use a method of contraception 30 days before inclusion into the group and to use a reliable method of contraception throughout the entire study;
- •Patients should not accept other forms of cosmetic intervention and agree to refrain from participation in any other clinical trials that may interrupt the study.
排除标准
- •The wrinkle severity of any site or both sites are either grade 0 or 5 on the 5-grade Wrinkle Severity Rating Scale.
- •The presence of facial hair that may influence the observation of wrinkle severity;
- •The area of injection had an apparent acne scar, active inflammation, infection, cancer or premalignancy, or untreated wound;
- •Patients who had facial plastic surgery, tissue transplant, silica gel, liposome (fat) injection, or other permanent or semipermanent dermal filler;
- •Patients who had any type of Botox injection in the last year or were injected more than 3 times.
研究组 & 干预措施
score 1 before injection
We injected 1-5 u of BoNTA into score 1 crow's feet lines before being included
干预措施: Botulinum toxin type A (Drug)
score 2 before injection
2-6 u of BoNTA into score 2 crow's feet lines
干预措施: Botulinum toxin type A (Drug)
score 3 before injection
3-10 u of BoNTA into score 3 crow's feet lines
干预措施: Botulinum toxin type A (Drug)
score 4 before injection
5-15 u of BoNTA into score 4 crow's feet lines.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
The change of wrinkle serenity rating scale after 2 weeks
时间窗: Two weeks after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale 2 weeks after Botox injection
The change of wrinkle serenity rating scale after three months
时间窗: Three months after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale three months after Botox injection
The change of wrinkle serenity rating scale after six months
时间窗: Six months after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale six months after Botox injection
The change of wrinkle serenity rating scale after nine months
时间窗: Nine months after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale nine months after Botox injection
The change of wrinkle serenity rating scale after one year
时间窗: One year after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale one year after Botox injection
The change of wrinkle serenity rating scale after one month
时间窗: One month after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale one month after Botox injection
次要结局
未报告次要终点
研究者
Qing-FengLi Li,MD
professor
Shanghai Jiao Tong University School of Medicine
