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

JRCT ID: jRCTs041180067

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Palmar hyperhidrosis
• Date of first enrollment: 01/03/2019
• Target sample size: 25
• Study type: Interventional
• Intervention(s): 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 palm, the same amount (unit, interval and injection number) is injected with a needle-free injector at the psi range between 130 and 160 (CO2 pressure for injections).

Outcome(s)

• Primary Outcome: Pain level on each palm right after injections (pain Visual Analogue Scale)

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 60age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Ohshima Yuichiro
• Source(s) of Monetary Support: MRTRAS. Inc.