Clinical Observation of Intradermal Injections With Botulinum Toxin A in the Treatment of Rosacea Erythema Telangiectasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CEA score
研究概览
简要总结
the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea.
详细描述
The main objective is to collect patients and then use different injection volumes of botulinum toxin intradermal injection for the treatment of rosacea erythema telangiectasia, and then to evaluate the clinical efficacy and safety of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Had received facial cosmetic surgery or botulinum toxin treatment within 6 months before this treatment;
- •due to systemic diseases such as autoimmune diseases or menopause facial flush;
- •had allergies botulinum toxin;
- •pregnant or breastfeeding;
- •other facial skin or oral disease therapy, including research before 4 weeks rose acne accept other treatment;
- •With basic neuromuscular diseases (such as myasthenia gravis, amyotrophic lateral sclerosis, etc.);
- •All landowners 4 weeks before the study whether any oral aminoglycoside drugs, benzodiazepines drugs or muscle relaxants; .Was removed during treatment observation data is not complete, incomplete treatment and patients can't take medication as prescribed.
研究组 & 干预措施
left cheek and right cheek
First, apply an appropriate amount of lidocaine cream to your face and wait (30-45 minutes) for the anesthetic to take effect;
Second step, after cleaning, mark the injection site on your face, about 25-30 points on one cheek, 1 cm apart, using a randomized half face control trial, Use of botulinum toxin type A for injection (Botox) (Allergan Pharmaceticals Ireland Limited, Import Drug Registration No. : S20171003), 0.5U botulinum toxin type A (Botox) was injected per point on one cheek and 1U on the other. The total amount of botulinum toxin type A was between 15 and 30U on each side.
干预措施: Botulinum Toxin Type A Injection [Botox] (Drug)
结局指标
主要结局
CEA score
时间窗: 2.4,8,12 weeks
Clinical erythema score (CEA) was divided into no, mild, moderate and severe according to the severity of rosacea, corresponding to 0,1,2,3, respectively
次要结局
- GAIS score(2.4,8,12 weeks)
研究者
dai jie
Nanjing First Hospital
Nanjing First Hospital, Nanjing Medical University