jRCTs041180084已完成不适用
The clinical utility of botulinum toxin type A for head/forehead hyperhidrosis (The clinical utility of botulinum toxin type A for head/forehead hyperhidrosis)
未提供0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 64age old under（—）
- 性别
- All
入选标准
- •Patients who meet the criteria of primary topical hyperhidrosis for head and forehead.
- •The Criteria of primary focal hyperhidrosis.
- •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 have symptom of irritation against component of botulinum toxin type A.
- •Women who are pregnant or may become pregnant and lactating women.
- •Patients with systemic neuromuscular junction dysfunction (myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis and others).
- •Patients who have received treatment with Botulinum toxin type A within 1 year and suspected the presence of neutralizing antibodies.
- •Patients who are using other types of botulinum toxin and (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: 6 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 at all evaluation points after administration(after administration)
- HDSS responder rate
研究者
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