Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Suction-curettage is a method in which the doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located. This method has been shown in some studies to effectively reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA) approved drug that in small doses, paralyses muscles. It is most commonly and famously used in the treatment of facial wrinkles. However, it has also been approved to treat excessive sweating. When injected in areas that sweat excessively, sweating can be significantly reduced in that area for months at a time. This study is a pilot study designed to determine feasibility of these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 to 65
- •BMI 18.5 - 29.99
- •Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
- •Subject is in good health
- •Subject has the willingness and ability to understand and provide informed consent
排除标准
- •Under age 18 or over age 65
- •Pregnancy or lactating
- •BMI ≥ 30 or ≤18.4
- •Subjects who have undergone axillary suction/curettage any time in the past
- •Subjects who have undergone axillary BT-A injections in the past year
- •Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
- •Subjects with a history of a bleeding disorder
- •Subjects with an open, non-healing sore or infection near site of procedure
- •Subjects with allergies to iodine, starch powder, albumin, or any botulinum toxin product
研究组 & 干预措施
Suction-Curettage
干预措施: Suction-Curettage (Device)
Botox
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
时间窗: baseline and 3 months
The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment. This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes. Percentage sweat rate was calculated as \[(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline\]\*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate.
次要结局
- The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment(Baseline and 3 months)
研究者
Murad Alam
Professor of Dermatology
Northwestern University