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Botulinum toxin type A for plantar hyperhidrosis

Phase 2
Recruiting
Conditions
plantar hyperhidrosis
Registration Number
JPRN-jRCTs041210062
Lead Sponsor
Ohshima Yuichiro
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

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:
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

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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