UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055593 |
|---|---|
| Receipt number | R000063531 |
| Scientific Title | The Effect of Lamellar-Structured Ceramide Lotion on the Skin Barrier Function of Operating Room Nurses' Hands: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2026/09/24 11:12:50 |
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Basic information
Public title
The Effect of Lamellar-Structured Ceramide Lotion on the Skin Barrier Function of Operating Room Nurses' Hands: A Randomized Controlled Trial
Acronym
Lamellar Lotion Hand RCT
Scientific Title
The Effect of Lamellar-Structured Ceramide Lotion on the Skin Barrier Function of Operating Room Nurses' Hands: A Randomized Controlled Trial
Scientific Title:Acronym
Lamellar Lotion Hand Barrier RCT
Region
| Japan |
Condition
Condition
Hand Dermatitis
Classification by specialty
| Dermatology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of lamellar-structured ceramide lotion on the skin barrier function of operating room nurses' hands.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal Water Loss (TEWL)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of Lamellar-Structured Ceramide Lotion
Interventions/Control_2
Control group not using the lamellar-structured ceramide lotion
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
Operating room nurses working at the Nagasaki Medical Center Surgical Department
No restrictions on age, gender, years of nursing experience, or years of experience in the operating room
Those who have received sufficient explanation of the study's purpose and content and have provided written informed consent of their own free will
Key exclusion criteria
Those holding the position of head nurse
Those using steroid ointments on their hands
Those with a history of atopic dermatitis in adulthood (excluding cases where remission occurred in childhood)
Those deemed unsuitable as study participants by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
NHO Nagasaki Medical Center
Division name
Operation Center
Zip code
856-8562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81957523121
haraken1124@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Operation Center
Zip code
8568562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81957523121
Homepage URL
haraken1124@gmail.com
Sponsor or person
Institute
NHO Nagasaki Medical Center Clinical Research Center
Institute
Department
Personal name
Funding Source
Organization
None
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
National Hospital Organization Nagasaki Medical Center Ethics Review Committee
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
Tel
+81957523121
haraken1124@gmail.com
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
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
in press
Publication of results
Unpublished
Result
URL related to results and publications
in press
Number of participants that the trial has enrolled
35
Results
This randomized controlled trial evaluated the effects of a ceramide-based lamellar emulsion on hand skin barrier function in 35 surgical nurses. Participants were assigned to an intervention group (n = 18, applying emulsion twice daily for 7 days) or a control group (n = 17, usual care).Transepidermal water loss (TEWL), the primary outcome, significantly decreased in the intervention group from Day 1 (p = 0.017) and remained significantly lower than in the control group on Days 3 and 7 (both p < 0.001).
Results date posted
| 2026 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-five surgical nurses completed the trial (intervention group: n = 18; control group: n = 17). Median age (IQR) was 38.5 (27.0-51.0) years in the intervention group and 32.0 (26.0-41.0) years in the control group. There were no statistically significant baseline differences between the groups regarding demographic characteristics or initial skin barrier parameters (baseline TEWL: 15.8 g/m2/h in intervention vs 19.4 g/m2/h in control; p = 0.135).
Participant flow
Thirty-five eligible surgical nurses were randomly allocated using stratified block randomization into either the intervention group (n = 18) or the control group (n = 17). The intervention group applied a lamellar ceramide emulsion twice daily (7 AM and 9 PM) for 7 days. The control group continued usual hand care. All 35 participants completed the 7-day follow-up and were included in the final analysis without any dropouts.
Adverse events
No adverse events related to the emulsion or study procedures were reported during the study period.
Outcome measures
Primary Outcome: Transepidermal water loss (TEWL, g/m2/h), measured at the dorsal web space of the dominant hand using VapoScan VT100RS.
Secondary Outcomes: Stratum corneum hydration (Mobile Moisture HP19-M), skin surface pH (HI981037), and clinical dry skin scores assessed from high-resolution dermoscopic images by a blinded plastic surgeon. Assessments were performed on Days 0, 1, 3, and 7.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063531
