jRCTs041210062招募中不适用
The clinical utility of botulinum toxin type A for plantar hyperhidrosis
未提供0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 主要终点
- Responder rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 20age old over 至 60age old under（—）
- 性别
- All
入选标准
- •Patients who meet the criteria of primary focal hyperhidrosis for plantar; Focal, visible, excessive sweating of at least 6 months duration without apparent cause with at least two of the following characteristics:
- •Age of onset less than 25 years
- •Bilateral and relatively symmetric
- •Cessation of focal sweating during sleep
- •Frequency of at least one episode per week
- •Positive family history
- •Impairs daily activities
排除标准
- •Patients who has symptom of irritation ag ainst component of botulinum toxin type A.
- •Preg nant women or women who may be pregnant.
- •Patients with systemic neuromuscular junction dysfunction (myasthenia g ravis, Lambert-Eaton synd
- •rome, amyotrophic lateral sclerosis and others).
- •Patients who was treated by botulinum toxin type A within 1 year and suspected the presence of neutralizing antibodies.
- •Patients who are using other types of botulinum toxin and muscle relaxants (tubocurarine chloride hydrochloride hydrate, dantrolene sodium hydrate and others).
- •In case a patient conducts other treatments for hyperhidrosis (external or internal medicine), s/he needs to have a washout period for 1 month.
结局指标
主要结局
Responder rate
时间窗: after 4 weeks from the first injections
The responder is defined as the perspiration amount is reduced by 50% or more as compared with the baseline in any item of the ventilation capsule method or the weight measurement method.
次要结局
- Responder rate of perspiration(4 weeks from first administration)
- Mean perspiration weight
- Rate of change from baseline of perspiration weight
- HDSS responder rate
- Amount of change from baseline of HDSS
- Total score of DLQI
- Score of each area of DLQI score
- Change of the score of each question of DLQI score from baseline
- Subject's satisfaction
- Duration of effect
研究者
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