UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027772 |
|---|---|
| Receipt number | 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 | 2024/06/24 17:19:37 |
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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
32
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
tnamderm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takichi |
| Middle name | |
| Last name | Munetsugu |
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
mtakderm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Hospital
Institute
Department
Personal name
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
tiken.crc@tmd.ac.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
32
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
Completed
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
| 2021 | Year | 09 | Month | 30 | 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
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031828
