UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027388 |
|---|---|
| Receipt number | R000031388 |
| Scientific Title | Change on stratum corneum hydration under natural indoor environment and controlled indoor environment |
| Date of disclosure of the study information | 2017/05/20 |
| Last modified on | 2022/05/23 09:06:42 |
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Basic information
Public title
Change on stratum corneum hydration under natural indoor environment and controlled indoor environment
Acronym
Change on stratum corneum hydration under natural environment and controlled environment
Scientific Title
Change on stratum corneum hydration under natural indoor environment and controlled indoor environment
Scientific Title:Acronym
Change on stratum corneum hydration under natural environment and controlled environment
Region
| Japan |
Condition
Condition
nursing
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The measured values of stratum corneum hydration under an environment controlled by room temperature and humidity assumed to be those of a clinical environment, and the measured values under the environment which was not controlled were compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of stratum corneum hydration due to difference between room temperature and humidity
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
| Maneuver |
Interventions/Control_1
The extremities of stratum corneum hydration measured after being for 15 minutes under controlled environment
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
Male and Female
Key inclusion criteria
people who can understand the question
Key exclusion criteria
patients with skin disease
patients with chemotherapy
patients with dialysis
patients with serious heart disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiyo Yamamoto |
Organization
Hokkaido University of Science
Division name
Health Science
Zip code
Address
7-15-4-1 Maeda, Teine, Sapporo
TEL
011-688-7149
yamamoto-m@hus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiyo Yamamoto |
Organization
Hokkaido University of Science
Division name
Health Science
Zip code
Address
7-15-4-1 Maeda, Teine, Sapporo
TEL
011-688-7149
Homepage URL
yamamoto-m@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
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
Address
Tel
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
| 2017 | Year | 05 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031388
