UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063021 |
|---|---|
| Receipt number | R000071942 |
| Scientific Title | Effectiveness of Moisturizing Skin Care in Patients with Diabetes Mellitus |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/15 16:44:17 |
* 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
Effectiveness of Moisturizing Skin Care in Patients with Diabetes Mellitus
Acronym
Diabetes Skin Care Study
Scientific Title
Effectiveness of Moisturizing Skin Care in Patients with Diabetes Mellitus
Scientific Title:Acronym
Diabetes Skin Care Study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 8-week moisturizing skin care on stratum corneum hydration in patients with type 2 diabetes mellitus.
Basic objectives2
Others
Basic objectives -Others
To characterize skin barrier function in patients with type 2 diabetes mellitus by comparison with healthy adults and to evaluate the effects of moisturizing skin care on skin barrier-related parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in stratum corneum hydration from baseline to 8 weeks after initiation of moisturizing skin care in patients with type 2 diabetes mellitus.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In the type 2 diabetes mellitus group, a moisturizing skin care product is applied to the flexor forearm once or twice daily for 8 weeks.
Interventions/Control_2
In the healthy adult group, a moisturizing skin care product is applied to the flexor forearm once or twice daily for 8 weeks.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 years or older who are either healthy or have type 2 diabetes mellitus. Patients with type 2 diabetes mellitus must have an HbA1c level of 6.5% or higher, and healthy participants must not have a diagnosis of type 2 diabetes mellitus.
Key exclusion criteria
Participants with skin diseases or treatments affecting skin barrier function, those undergoing dialysis, those routinely using moisturizers or topical agents on the assessment site, those who participated in another clinical study within the previous 4 months, or those judged unsuitable by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakai |
Organization
Oita University
Division name
Department of Dermatology, Faculty of Medicine
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita
TEL
+81-97-586-5882
t-sakai@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sakai |
Organization
Oita University
Division name
Department of Dermatology, Faculty of Medicine
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita
TEL
+81-97-586-5882
Homepage URL
t-sakai@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Clinical Research Center, Oita University Hospital
Address
1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita
Tel
+81-97-586-6163
gcrcjimu@oita-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
| 2026 | Year | 10 | 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
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
| 2026 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2026 | Year | 09 | Month | 22 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071942
