Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
研究概览
简要总结
Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment. Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and 24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients before and after treatment. The satisfaction and adverse reactions of the research participants were recorded at every follow-up visit.
详细描述
Hyperhidrosis Disease Severity Scale (HDSS)Score = 1 My sweating is never noticeable and never interferes with my daily activitiesScore = 2 My sweating is tolerable but sometimes interferes with my daily activitiesScore = 3 My sweating is barely tolerable and frequently interferes with my daily activitiesScore = 4 My sweating is intolerable and always interferes with my daily activities
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the following conditions
- •Diagnosed according to having a score of 3 or 4 on a Hyperhidrosis Disease
- •Severity Scale (HDSS);
- •Patients aged 18 to 40 years (to the date of screening);
- •Not treatment in Axillary area before;
- •Understanding the whole process of the study, voluntary participation and signed the informed consent;
- •Patient compliance is good, can guarantee in course of observation.
排除标准
- •One of the following is not included in this study:
- •Pregnant women, ready to pregnant or lactating women;
- •Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
- •Need insulin control of diabetes; High blood pressure did not get good controller ;
- •Patients with white blood cells <4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets <100 × 109 / L, or other blood disease;
- •Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
- •Patients suffering from malignant tumor;
- •Patients suffering from acute and chronic infectious diseases;
- •Mental disorders, history of alcohol abuse, drug or other substance abuse;
- •Other cases which researchers believe that can not enroll.
研究组 & 干预措施
Fractional Microneedle Radiofrequency Treatment
Fractional Microneedle Radiofrequency Treatment
干预措施: Fractional microneedle RF(United, Peninsula Medical, China) (Device)
结局指标
主要结局
The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
时间窗: up to 24 weeks
次要结局
- The improvement of visual analog scale(VAS) by patient(0 week, 4weeks, 8weeks, 24 weeks)
研究者
xjpfW
chief of dermatology
Xijing Hospital