Botulinum Toxin Type A with Needle-free Injector System in Palmar Hyperhidrosis
- Conditions
- Palmar hyperhidrosis
- Registration Number
- JPRN-jRCTs041180067
- Lead Sponsor
- Ohshima Yuichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain level on each palm right after injections (pain Visual Analogue Scale)
- Secondary Outcome Measures
Name Time Method Treatment time on each palm.<br>Average perspiration amount, HDSS score, DLQI score, patient-satisfaction level and duration of efficacy: at all time points on each palm.