UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004254 |
|---|---|
| Receipt number | R000005077 |
| Scientific Title | Analysis of efficacy of butulinum toxin type A treatment for compensatory hyperhidrosis |
| Date of disclosure of the study information | 2010/10/08 |
| Last modified on | 2013/03/26 13:27:45 |
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Basic information
Public title
Analysis of efficacy of butulinum toxin type A treatment for compensatory hyperhidrosis
Acronym
Efficacy of butulinum toxin type A against compensatory hyperhidrosis
Scientific Title
Analysis of efficacy of butulinum toxin type A treatment for compensatory hyperhidrosis
Scientific Title:Acronym
Efficacy of butulinum toxin type A against compensatory hyperhidrosis
Region
| Japan |
Condition
Condition
Compensatory hyperhidrosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of novel treatment for Compensatory hyperhidrosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perspiration of sweat
Key secondary outcomes
Degree of satisfaction for patients
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Period (observation of six months)
100 unit of Botulinum toxin type A local injection with one time
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who caused compensatory hyperhidrosis after ETS (Endoscopic Thoracic Sympathectomy) etc.
Key exclusion criteria
Minority's patients
Patients who are continuing other treatments
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tamada |
Organization
Aichi Medical University school of Medicine
Division name
Dermatology
Zip code
Address
1-1 Karimata Nagakute Aichi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aichi Medical University school of Medicine
Division name
Dermatology
Zip code
Address
1-1 Karimata Nagakute Aichi
TEL
Homepage URL
Sponsor or person
Institute
Department of Dermatology Aichi Medical University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛知医科大学付属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 08 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 22 | Day |
Last modified on
| 2013 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005077
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
