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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180067
Enrollment
25
Registered
2019-03-07
Start date
2019-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palmar hyperhidrosis Palmar hyperhidrosis

Interventions

As for the left palm, 2 units of Botulinum toxin type A is injected at 1-1.5cm intervals (approximately 50 injections in total) after anesthesia cream and ice cooling are applied. As for the right pal

Sponsors

Ohshima Yuichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Pain level on each palm right after injections (pain Visual Analogue Scale)

Secondary

MeasureTime frame
Treatment time on each palm. Average perspiration amount, HDSS score, DLQI score, patient-satisfaction level and duration of efficacy: at all time points on each palm.

Contacts

Public ContactYuichiro Ohshima

Aichi Medical University Hospital

y45123@aichi-med-u.ac.jp+81-561-62-3311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026