JPRN-jRCTs041180084已完成2 期
The clinical utility of botulinum toxin type A for head/forehead hyperhidrosis - The clinical utility of botulinum toxin type A for head/forehead hyperhidrosis
Ohshima Yuichiro0 个研究点目标入组 15 人开始时间: 2019年3月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
We performed local injection therapy of botulinum toxin type A for patients with head and forehead hyperhidrosis and evaluated its efficacy and duration, safety, and patient satisfaction. As a result, good efficacy and safety, patients Satisfaction was obtained. In addition, the duration of efficacy was relatively long, 30 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 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:
- •1) Age of onset less than 25 years
- •2) Bilateral and relatively symmetric
- •3) Cessation of focal sweating during sleep
- •4) Frequency of at least one episode per week
- •5) Positive family history
- •6) 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.
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