UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059964 |
|---|---|
| Receipt number | R000068554 |
| Scientific Title | Randomized Controlled Trial Comparing Moisturizer Provision Methods for the Prevention of Hand Eczema in Ward Nurses |
| Date of disclosure of the study information | 2025/12/04 |
| Last modified on | 2025/12/04 10:23:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized Controlled Trial Comparing Methods of Providing Moisturizers to Prevent Hand Eczema in Ward Nurses
Acronym
A Study on Moisturizing Methods to Prevent Hand Eczema in Ward Nurses
Scientific Title
Randomized Controlled Trial Comparing Moisturizer Provision Methods for the Prevention of Hand Eczema in Ward Nurses
Scientific Title:Acronym
Moisturizer Provision RCT for Hand Eczema in Nurses
Region
| Japan |
Condition
Condition
hand eczema
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthcare workers perform hand hygiene more frequently than non-healthcare workers, resulting in a higher incidence of hand eczema, which often becomes chronic and difficult to manage. Among them, ward nurses have particularly high hand hygiene demands in their daily practice, and previous studies have reported that they have a higher incidence of hand eczema and are more prone to severe disease.
Topical moisturizers are widely recommended as a preventive measure for hand eczema. However, in actual clinical settings, they are often underused due to barriers such as inconvenience and the lack of a habitual moisturizing routine.
In this study, ward nurses will be assigned to one of three groups: (1) individual distribution of moisturizers, (2) placement of moisturizers within the ward, and (3) no provision of moisturizers. The impact of each approach on hand eczema will be compared and evaluated.
The aim of this study is to clarify the effect of topical moisturizers on hand eczema and to identify the most effective method of providing moisturizers. Ultimately, this research seeks to establish practical and feasible strategies for the prevention and management of hand eczema in healthcare settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in hand eczema scores (self-rated on a 0 to 10 scale) between groups at baseline, 6 weeks, and 12 weeks after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Moisturizers will be individually distributed to the intervention group. Each participant will receive one box containing ten 25 g tubes and will use them during working hours. The frequency and timing of application will not be specified and will be left to the discretion of each participant. The intervention period will be 12 weeks, and the weight of the moisturizer will be measured at 6 and 12 weeks to assess the amount used.
Interventions/Control_2
Moisturizers will be placed in the wards for the intervention group. Pump containers filled with approximately 300 g of moisturizer will be placed in shared areas within the target wards (e.g., nurse stations and washstands) to allow free use. The intervention period will be 12 weeks, and the weight of the moisturizer will be measured at 6 and 12 weeks to assess the amount used.
Interventions/Control_3
In the control group, neither distribution nor placement of moisturizers will be conducted.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Based on the results of a hand eczema survey conducted on all staff working at our hospital from July 14 2025 to July 25 2025, six wards were selected as the target. Among the nurses working in the designated wards, those who provide consent to participate in the study (25 to 30 nurses per ward) will be selected.
Key exclusion criteria
Participants who are known in advance to be unable to continue participation until the end of the 12 week observation period due to resignation or leave of absence
Participants who are judged at the time of obtaining consent to have insufficient ability to understand the purpose and content of the study
Participants whom the principal investigator judges to be inappropriate for participation in this study
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | ARIMA |
| Middle name | |
| Last name | AI |
Organization
Nara Medical University
Division name
Department of Dermatology
Zip code
634-8522
Address
840 Shijo-cho Kashihara-shi Nara
TEL
0744223051
ai_214_littlestar@yahoo.co.jp
Public contact
Name of contact person
| 1st name | ARIMA |
| Middle name | |
| Last name | AI |
Organization
Nara Medical University
Division name
Department of Dermatology
Zip code
634-8522
Address
840 Shijo-cho Kashihara-shi Nara
TEL
0744223051
Homepage URL
ai_214_littlestar@yaho.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
840 Shijo-cho Kashihara-shi Nara
Tel
0744223051
ai_214_littlestar@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
| 2025 | Year | 12 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068554
