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

Ohshima Yuichiro0 sites15 target enrollmentMarch 12, 2019

ConditionsHead/forehead hyperhidrosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head/forehead hyperhidrosis
Sponsor: Ohshima Yuichiro
Enrollment: 15
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

who.int

Start Date

March 12, 2019

End Date

June 26, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Ohshima Yuichiro

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.