UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035418
Receipt number R000040352
Scientific Title Evaluation of hand care for hand eczema in hospital staff
Date of disclosure of the study information 2019/02/01
Last modified on 2021/10/15 12:09:52

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Basic information

Public title

Evaluation of hand care for hand eczema in hospital staff

Acronym

hand eczema of hospital staff

Scientific Title

Evaluation of hand care for hand eczema in hospital staff

Scientific Title:Acronym

hand eczema of hospital staff

Region

Japan


Condition

Condition

hand eczema

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Improvement of hand eczema in hospital staff by hand care to prevent in-hospital transmission

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Hand eczema severity index 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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply moisturizer four times a day and wear gloves at bedtime

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 nurse with hands eczema more than moderate in both hands

Key exclusion criteria

Those which research managers judged inappropriate as research subjects

Target sample size

10


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

Email

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


Email

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

Email

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

2019 Year 02 Month 01 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

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

2019 Year 02 Month 20 Day

Date of IRB

2019 Year 02 Month 20 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2020 Year 08 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

2018 Year 12 Month 31 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=R000040352


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name