Skip to main content
Clinical Trials/JPRN-jRCTs041180067
JPRN-jRCTs041180067
Recruiting
Phase 2

A Clinical Study of Botulinum Toxin Type A with Needle-free Injector System in Palmar Hyperhidrosis - A Clinical Study of Botulinum Toxin Type A with Needle-free Injector System in Palmar Hyperhidrosis

Ohshima Yuichiro0 sites25 target enrollmentMarch 7, 2019

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Palmar hyperhidrosis
Sponsor
Ohshima Yuichiro
Enrollment
25
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 7, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ohshima Yuichiro

Eligibility Criteria

Inclusion Criteria

  • Patients who meet 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

Exclusion Criteria

  • Patients who has symptom of irritation against component of botulinum toxin type A.
  • Pregnant women or women who may be pregnant.
  • Patients with systemic neuromuscular junction dysfunction (myasthenia gravis, Lambert\-Eaton syndrome, 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.

Outcomes

Primary Outcomes

Not specified

Similar Trials