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The clinical utility of botulinum toxin type A for head/forehead hyperhidrosis (The clinical utility of botulinum toxin type A for head/forehead hyperhidrosis)

Botulinum toxin type A for head/forehead hyperhidrosis (Botulinum toxin type A for head/forehead hyperhidrosis)

15

The average age was 41.7 years (25-62 years), 12 males and 3 females, the average HDSS was 3.13, and the average DLQI was 9.2.

The registration pace was almost as expected compared to the initially predicted pace. The 15 people specified in the research plan were reached in about one year from the start of registration. There was no discontinuation for the entire period other than the discontinuation specified in the protocol at the time of loss of efficacy (when the average sweating rate was first observed to exceed 50% of baseline after administration of botulinum toxin type A). .. There were no serious adverse events.

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

In this study, the primary endpoint of efficacy was the responder rate by ventilation capsule method or weight measurement 6 weeks after the initial administration. The responder was defined as a subject whose sweating amount was reduced by 50% or more compared to the baseline in either the ventilation capsule method or the weight measurement method. All subjects reached the primary endpoint, demonstrating immediate efficacy after the procedure. The duration of efficacy was 30 weeks. Even at the time when it is determined that the efficacy has been lost in the sweat rate (30 weeks later), both HDSS and DLQI continued to maintain a relatively low value.

We performed local injection therapy of botulinum toxin type A for patients with head and forehead hyperhidrosis and evaluated its efficacy and duration, safety, and patient satisfaction. As a result, good efficacy and safety, patients Satisfaction was obtained. In addition, the duration of efficacy was relatively long, 30 weeks.

May. 05, 2022

No

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https://jrct.mhlw.go.jp/latest-detail/jRCTs041180084

Ohshima Yuichiro

Aichi Medical University Hospital

1-1 Yazakokarimata, Nagakute, Aichi Japan

y45123@aichi-med-u.ac.jp

Ando Yoriko

Aichi Medical University Hospital

1-1 Yazakokarimata, Nagakute, Aichi Japan

+81-561-62-3311

yorion1441@yahoo.co.jp

Complete

Sept. 08, 2017

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who meet the criteria of primary topical hyperhidrosis for head and forehead.
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 have symptom of irritation against component of botulinum toxin type A.
Women who are pregnant or may become pregnant and lactating women.
Patients with systemic neuromuscular junction dysfunction (myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis and others).
Patients who have received treatment with Botulinum toxin type A within 1 year and suspected the presence of neutralizing antibodies.
Patients who are using other types of botulinum toxin and (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

Head/forehead hyperhidrosis

At head and forehead, 2 units (0.08ml) of Botulinum toxin type A is injected at 1-1.5cm intervals (Head;20-30 injections, Forehead; 20-30injections, approximately 50 injections in total) to avoid eyelid ptosis Approximately 1 cm away from the eyebrow.

Head/forehead hyperhidrosis

Responder rate measured by ventilated capsule method and weight measuring method after 6 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 6 weeks from first administration is the main evaluation), mean perspiration weight, rate of change from baseline of perspiration weight, HDSS responder rate (Percentage of subjects whose HDSS score improved by 2 points or more from baseline), The amount of change from the baseline of HDSS, the total score of the score of DLQI, the score of each area of DLQI score, the change of the score of each question of DLQI score from baseline, subject's satisfaction and duration of effect.

+81-561-62-3311

Feb. 25, 2019

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