UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026576 |
|---|---|
| Receipt number | R000025775 |
| Scientific Title | Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2023/11/27 12:21:23 |
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Basic information
Public title
Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Acronym
Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Scientific Title
Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Scientific Title:Acronym
Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Region
| Japan |
Condition
Condition
healthy control and atopic dermatitis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of sweating response and skin structure associated with heparinoid containing moisturizer and steroid ointment.
Basic objectives2
Others
Basic objectives -Others
sweating response and alternation of skin folds.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Status of sweating after application for 2 weeks.
Key secondary outcomes
Skin surface hydration, texture of skin.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
moisturizer and base.
Interventions/Control_2
7 days and 14 days.
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
1.Person older than 20yo.
2.Person who agree to participate in this trial.
3.Healthy person or patient with AD.
Key exclusion criteria
1.Person with allergic dermatitis.
2.Person with sweat disturbance.
3.Person who has hypersensitivity for moisturizer and base.
4.Person who enrolled in other clinical trial within a month.
5.Person who was disqualified by principal clinician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Aoyama |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
ymaoyama@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Aoyama |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
700-0192
Address
2-1-80, Nakasannge, Kitaku, Okayama, Japan
TEL
086-225-2111
Homepage URL
kmsrec@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Research ethics committee of kawasaki medical school and hospital
Address
577, Matsushima, Kurashiki, Okayama, Japan
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 29 | 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
Monitoring ended September 8, 2020 No problems
Monitoring ends March 22, 2021 No problems
Monitoring ends September 28, 2021 No problem
Monitoring ends May 23, 2022 No problems
Monitoring was scheduled for September 2022, but it has not been implemented as there are no applicable persons No problem
Monitoring ends April 21, 2023 No problems
Monitoring ended on November 27, 2023 No problems
Management information
Registered date
| 2017 | Year | 03 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025775
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
