Botulinum toxin type A for plantar hyperhidrosis

JRCT ID: jRCTs041210062

Registered date:01/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: plantar hyperhidrosis
• Date of first enrollment: 01/09/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): As for the left plantar, Botulinum toxin type A is injected at 1-1.5cm intervals (approximately 50 injections in total) after anesthesia cream and ice cooling are applied. We use 34G needle. 100 units group is 20 cases. 200 units group is 20 cases. 100 units group: 2 units/ spot (0.1ml) of Botulinum toxin type A is injected (approximately 50 injections in total). 200 units group: 4 units/ spot (0.1ml) of Botulinum toxin type A is injected (approximately 50 injections in total).

Outcome(s)

Primary Outcome

Responder rate measured by ventilated capsule method and weig ht measuring method after 4 weeks from the first injections.
The responder is defined as the perspiration amount is reduced by 50% or more as compared with the baseline in any item of the ventilation capsule method or the weight measurement method.

Secondary Outcome

Responder rate of perspiration at all evaluation points after administration (responder rate measured after 4 weeks from first administration is the main evaluation), mean perspiration weight, rate of chang e from baseline of perspiration weig ht, HDSS responder rate (Percentag e of subjects whose HDSS score improved by 2 points or more from baseline), The amount of chang e from the baseline of
HDSS, the total score of the score of DLQI, thescore of each area of DLQI score, the chang e of the score of each question of DLQI score from baseline, subject's satisfaction and duration of effect.
We compare the 100 and 200 units group for all items.

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 for plantar; 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 ag ainst component of botulinum toxin type A.
Preg nant women or women who may be pregnant.
Patients with systemic neuromuscular junction dysfunction (myasthenia g ravis, Lambert-Eaton synd
rome, 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