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
ConditionsPalmar hyperhidrosis
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.
Investigators
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
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