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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027772
Receipt No. R000031828
Scientific Title The efficacy of a microwave device for treating axillary hyperhidrosis: Split-patient (1Pass vs 2Pass) comparative study
Date of disclosure of the study information 2017/06/16
Last modified on 2019/06/17

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Basic information
Public title The efficacy of a microwave device for treating axillary hyperhidrosis: Split-patient (1Pass vs 2Pass) comparative study
Acronym The efficacy of a microwave device for treating axillary hyperhidrosis
Scientific Title The efficacy of a microwave device for treating axillary hyperhidrosis: Split-patient (1Pass vs 2Pass) comparative study
Scientific Title:Acronym The efficacy of a microwave device for treating axillary hyperhidrosis
Region
Japan

Condition
Condition primary axillary hyperhidrosis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evidence for an effective and safe treatment protocol in this treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of sweating amount by gravimetric method: amount of perspiration at 24 weeks after treatment between 1 or 2 pass groups
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Once per treatment
Interventions/Control_2 Twice per treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) over 20 years old
(2) hyperhidrosis in both axillary bilateral symmetry
Axillary hyperhidrosis is the case where locally excessive perspiration is observed for more than 6 months without obvious cause and more than 2 of the following 6 symptoms apply
1)appear to be 25 years or younger
2)Sweating is seen in symmetry
3)Sweating stops while sleeping
4)episodes of multiple perspiration at least once in a week
5)have a family history
6)to interfere with everyday life by them
(3) perspiration from each axilla is 50 mg / 5 minutes or more
(4) HDSS 3 or 4
Key exclusion criteria (1) Secondary hyperhidrosis
(2) Frey syndrome
(3) Topical application of aluminum chloride within 4 weeks of consent acquisition
(4) Local injection of botulinum toxin type A was conducted within one year of consent acquisition
(5) Oral intake of anticholinergic drug within 2 weeks of acquiring consent
(6) I underwent surgery on the axillary part
(7) Serious underlying disease (history of xylocaine shock)
(8) Diseases requiring systemic administration such as steroids
(9) Systemic diseases such as collagen diseases that have impaired wound healing
(10) any type of pacemaker implantation
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Namiki
Organization Tokyo Medical and Dental University hospital
Division name Dermatology
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan
TEL 03-5803-5286
Email tnamderm@tmd.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Yoshioka
Organization Tokyo Medical and Dental University Hospital
Division name Dermatology
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan
TEL 03-5803-5286
Homepage URL
Email y_yoshioka_0331@yahoo.co.jp

Sponsor
Institute Tokyo Medical and Dental University Hospital
Institute
Department

Funding Source
Organization JMEC Co.,LTD
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan
Tel 03-5803-5286
Email y_yoshioka_0331@yahoo.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 08 Month 10 Day
Date of IRB
2017 Year 10 Month 20 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 15 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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