UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042108 |
|---|---|
| Receipt number | R000048057 |
| Scientific Title | Efficacy of daily fabric gloves for hand eczema in health care workers. |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2021/10/15 12:28:11 |
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Basic information
Public title
Efficacy of daily fabric gloves for hand eczema in health care workers.
Acronym
fabric gloves for hand eczema
Scientific Title
Efficacy of daily fabric gloves for hand eczema in health care workers.
Scientific Title:Acronym
fabric gloves for hand eczema
Region
| Japan |
Condition
Condition
hand eczema
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
observe the effects of fabric gloves on hand eczema in health care workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hand eczema severity index score 4 weeks after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
wear cotton glove on the left hand at bedtime. Do not wear on the right hand.
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
Female
Key inclusion criteria
NICU/GCU nurses with hand eczema more than moderate in both hands.
Key exclusion criteria
Subjects with clear difference in hand eczema severity between left and right hand.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuwatsuka |
Organization
Nagasaki university hospital
Division name
Department of Dermatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7333
s-kuwa22@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuwatsuka |
Organization
Nagasaki university hospital
Division name
Department of Dermatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7333
Homepage URL
s-kuwa22@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Nagasaki university hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel
095-819-7333
s-kuwa22@nagasaki-u.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
| 2020 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
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
| 2020 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | 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
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048057
