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Oct. 05, 2018 |
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Aug. 01, 2024 |
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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) |
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The efficacy of a microwave device for treating axillary hyperhidrosis (The efficacy of a microwave device for treating axillary hyperhidrosis) |
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July. 14, 2021 |
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32 |
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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) |
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32 enrolled cases 2 cases dropped out, 5 cases discontinued |
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No adverse events or serious adverse events except one skin ulcer, one burn, and one case of pain. |
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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 |
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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. |
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Aug. 01, 2024 |
No |
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N/A |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs032180023 |
Namiki Takeshi |
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Tokyo Medical and Dental Univ. Medical Hospital |
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1-5-45, Yushima, Bunkyo-ku, Tokyo |
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+81-3-5803-5286 |
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tnamderm@tmd.ac.jp |
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Munetsugu Takichi |
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Tokyo Medical and Dental Univ. Medical Hospital |
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1-5-45, Yushima, Bunkyo-ku, Tokyo |
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+81-3-5803-5286 |
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mtakderm@tmd.ac.jp |
Complete |
Nov. 01, 2017 |
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| Dec. 28, 2017 | ||
| 32 | ||
Interventional |
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randomized controlled trial |
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double blind |
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dose comparison control |
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parallel assignment |
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treatment purpose |
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Primary axillary hyperhidrosis |
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Secondary hyperhidrosis, Frey syndrome |
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| 20age old over | ||
| 64age old not | ||
Both |
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Primary axillary hyperhidrosis |
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The sweat glands were treated with a microwave device |
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hyperhidrosis, microwave device, miraDry |
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088/088 |
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Comparison of sweating weight 24 weeks after treatment (1Pass vs 2Pass) |
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The difference in maximum sweating weight of 1 pass / 2 pass during exercise at 24 weeks after treatment |
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| 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 |
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| mkan-rinsho.adm@cmn.tmd.ac.jp | |
| Approval | |
July. 20, 2018 |
| UMIN000027772 | |
| UMIN |
None |