plantar hyperhidrosis plantar hyperhidrosis
Conditions
Interventions
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
Sponsors
Ohshima Yuichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactYuichiro Ohshima
Aichi Medical University Hospital
Outcome results
None listed