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The clinical utility of botulinum toxin type A for plantar hyperhidrosis

Botulinum toxin type A for plantar hyperhidrosis

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Botulinum toxin type A 200-unit group. Patients: Nine cases. The mean age of the patients was 39.8 year, the mean age of onset was 8.78 years, the mean HDSS score was 3.11, and the mean DLQI was 6.12. Botulinum toxin type A 100-unit group. Patients: Seven cases. The mean age of the patients was 35.4 years, the mean age of onset was 7.57 years, the mean HDSS score was 3.14, and the mean DLQI was 6.32.

The planned number of cases was 40. Due to the impact of COVID-19, only 16 cases were conducted. No cases were discontinued throughout the entire period. There were no serious adverse events.

Throughout the entire observation period, there were no serious side effects.

Both the BTX-A 200-unit group and the 100-unit group showed a reduction in sweat volume four weeks after drug administration. A significant decrease in sweating was maintained up to 20 weeks in the BTX-A 200-unit group and up to 12 weeks in the 100-unit group. HDSS and DLQI scores significantly decreased at four weeks after treatment in the BTX-A 200-unit group, whereas in the 100-unit group, they decreased but not significantly.

Local injection therapy with botulinum toxin type A for plantar hyperhidrosis was found to reduce sweat production. The 200-unit group demonstrated a longer duration of sweat suppression. At 4 weeks after treatment, both HDSS and DLQI scores decreased in both groups; however, in the 200-unit group, the decreases were statistically significant compared with baseline values. These results suggest that approximately 200 units per foot may be necessary to achieve sufficient therapeutic efficacy.

Dec. 31, 2025

No

There is no plan to share data.

https://jrct.mhlw.go.jp/latest-detail/jRCTs041210062

Ohshima Yuichiro

Aichi Medical University Hospital

1-1 Yazakokarimata, Nagakute, Aichi Japan

y45123@aichi-med-u.ac.jp

Ohshima Yuichiro

Aichi Medical University Hospital

1-1 Yazakokarimata, Nagakute, Aichi Japan

+81-561-62-3311

y45123@aichi-med-u.ac.jp

Complete

Sept. 01, 2021

Interventional

randomized controlled trial

single blind

dose comparison control

parallel assignment

treatment purpose

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

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.

Both

plantar hyperhidrosis

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).

plantar hyperhidrosis

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.

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.

+81-561-62-3311

May. 07, 2021

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