UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038647 |
|---|---|
| Receipt number | R000043838 |
| Scientific Title | Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study |
| Date of disclosure of the study information | 2019/11/20 |
| Last modified on | 2020/06/20 20:29:12 |
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Basic information
Public title
Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study
Acronym
Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study
Scientific Title
Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study
Scientific Title:Acronym
Longitudinal change on the skin barrier functions by application of moisturizers: an experimental study
Region
| Japan |
Condition
Condition
non-atopic adults, atopic dermatitis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In adult volunteers with no history of atopic dermatitis and adult volunteers with a history of atopic dermatitis, the longitudinal changes in the stratum corneum by application of moisturizers will be examined using a confocal Raman spectroscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Water content of stratum corneum and specific molecules (natural moisturizing factor, urea, urocanic acid, ceramide, cholesterol, etc.) measured by confocal Raman spectroscopy.
Key secondary outcomes
2. Stratum corneum pH
3. Water content of stratum corneum
4. TEWL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply about 0.5g of Pigeon Baby Cream f on one forearm and Pigeon Vaseline on the other forearm. Apply once a day after bathing and continue daily for 28 days (+7 days) until the end of the third measurement.
Interventions/Control_2
Apply about 0.5g of Pigeon Baby Cream f on the forearm different from Intervention 1 and Pigeon Vaseline on the other forearm. Apply once a day after bathing and continue daily for 28 days (+7 days) until the end of the third measurement.
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
Those who are 20 years of age or older when obtaining consent
Key exclusion criteria
1) Those who have been diagnosed with allergies to moisturizers
2) Those who have taken steroids or immunosuppressants for one month prior to registration
3) Those who have used topical steroids or tacrolimus for the forearm within one month before registration
4) Participants in other usage tests
5) Those who are determined to be inappropriate for study participation by the study doctor or study director
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Yoshida |
Organization
National Center for Child Health and Development
Division name
Division of Dermatology
Zip code
157-8535
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535
TEL
03-3416-0181
skin_research@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Mochimaru |
Organization
National Center for Child Health and Development
Division name
Division of Dermatology
Zip code
157-8535
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535
TEL
03-3416-0181
Homepage URL
skin_research@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Pigeon 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
National Center for Child Health and Development
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535
Tel
03-3416-0181
rinri@ncchd.go.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
| 2019 | Year | 11 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 11 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043838
