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Oct. 05, 2018

Aug. 01, 2024

jRCTs032180023

The efficacy of a microwave device for treating axillary hyperhidrosis: Split-patient (1Pass vs 2Pass) comparative study (The efficacy of a microwave device for treating axillary hyperhidrosis: Split-patient (1Pass vs 2Pass) comparative study)

The efficacy of a microwave device for treating axillary hyperhidrosis (The efficacy of a microwave device for treating axillary hyperhidrosis)

July. 14, 2021

32

Total of 28 patients: 9 males and 19 females (19 of whom were eligible for the primary endpoint, excluding 9 cases with missing primary endpoints or missing endpoints that could have affected sweating volume) Age ranged from 25 to 58 (mean 40.78)

32 enrolled cases 2 cases dropped out, 5 cases discontinued

No adverse events or serious adverse events except one skin ulcer, one burn, and one case of pain.

Primary endpoint Difference in sweating weight between one and two passes at 24 weeks post-treatment No statistically significant difference Secondary endpoints Difference in maximum sweating weight between 1 and 2 paths at 24 weeks post-treatment No statistically significant difference Difference in degree between 1-pass and 2-pass at 24 weeks post-treatment in patients with odor complications 2 patients with odor in either 1 pass or 2 passes, no significant difference in odor between 1 pass and 2 passes Difference in incidence of adverse events No adverse events or serious adverse events except skin ulcers and burns in one case and pain in one case

There was no significant difference in sweating weight between the 1- and 2-pass treatments. There was no significant difference in the occurrence of adverse events between the 1-and 2-pass treatments on the day of treatment and 1-2 days after treatment, but there was a significant difference in the occurrence of swelling at 2 and 4 weeks after treatment, which was more common in the 2-pass treatment.

Aug. 01, 2024

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180023

Namiki Takeshi

Tokyo Medical and Dental Univ. Medical Hospital

1-5-45, Yushima, Bunkyo-ku, Tokyo

+81-3-5803-5286

tnamderm@tmd.ac.jp

Munetsugu Takichi

Tokyo Medical and Dental Univ. Medical Hospital

1-5-45, Yushima, Bunkyo-ku, Tokyo

+81-3-5803-5286

mtakderm@tmd.ac.jp

Complete

Nov. 01, 2017

Dec. 28, 2017
32

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

Primary axillary hyperhidrosis

Secondary hyperhidrosis, Frey syndrome

20age old over
64age old not

Both

Primary axillary hyperhidrosis

The sweat glands were treated with a microwave device

hyperhidrosis, microwave device, miraDry

088/088

Comparison of sweating weight 24 weeks after treatment (1Pass vs 2Pass)

The difference in maximum sweating weight of 1 pass / 2 pass during exercise at 24 weeks after treatment
Difference in perspiration of 1 pass / 2 pass 24 weeks after treatment with odor complications
Difference in adverse event occurrence rate between 1 pass and 2 pass during the research period

JMEC Co.,LTD
Not applicable
Tokyo Medical and Dental University Review Board of Clinical Study
1-5-45, Yushima, Bunkyo-ku, Tokyo, Tokyo

+81-3-5803-4575

mkan-rinsho.adm@cmn.tmd.ac.jp
Approval

July. 20, 2018

UMIN000027772
UMIN

None

History of Changes

No Publication date
7 Aug. 01, 2024 (this page) Changes
6 Sept. 07, 2023 Detail Changes
5 July. 22, 2020 Detail Changes
4 Mar. 11, 2020 Detail Changes
3 Feb. 20, 2020 Detail Changes
2 Dec. 04, 2019 Detail Changes
1 Oct. 05, 2018 Detail