UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059678 |
|---|---|
| Receipt number | R000068020 |
| Scientific Title | Skin Condition Data Collection Study |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/04 18:15:11 |
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Basic information
Public title
Skin Condition Data Collection Study
Acronym
Skin Condition Data Collection Study
Scientific Title
Skin Condition Data Collection Study
Scientific Title:Acronym
Skin Condition Data Collection Study
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect basal skin condition data
Basic objectives2
Others
Basic objectives -Others
To collect basal skin parameter data at different times of the day
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal Water Loss (TEWL), Stratum Corneum Hydration (SCH), and Subjective Skin Assessment Questionnaire scores
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females aged 20 years to less than 60 years from informed consent to the end of the study.
2. Individuals who are able to present to the designated facility on the scheduled visit day for Health Examination 2.
3. Individuals who self-aware of having dry skin.
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Subjects whose systolic blood pressure is less than 90 mmHg
2. Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
3. Subjects who are applicable to following items
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs.
c) Subjects who are contracting diabetes.
d) Subjects with a history of cancer, tuberculosis, or other serious illness
4. Smoker
5.Subjects who drink a lot.
6. Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
CPCC Company Limited
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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 | 11 | Month | 07 | 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 | 10 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To collect basal skin parameter data from subjects who meet the inclusion criteria and do not meet the exclusion criteria among participants recruited through a volunteer bank at November 2025.
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068020
