UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036894 |
|---|---|
| Receipt number | R000042045 |
| Scientific Title | An analysis of skin surface components for infantile disease skin. |
| Date of disclosure of the study information | 2019/07/11 |
| Last modified on | 2020/06/09 17:33:33 |
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Basic information
Public title
An analysis of skin surface components for infantile disease skin.
Acronym
An analysis of infantile skin surface components.
Scientific Title
An analysis of skin surface components for infantile disease skin.
Scientific Title:Acronym
An analysis of infantile skin surface components.
Region
| Japan |
Condition
Condition
Infants with skin disease
Infants with healthy skin
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify biological marker which characterize skin disease
Basic objectives2
Others
Basic objectives -Others
To identify biological marker which characterize skin disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of skin surface components and dermatological assessment of disease/healthy skin infants.
Key secondary outcomes
Questionnaire of skin and health condition of disease/healthy skin infants.
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
| 6 | months-old | <= |
Age-upper limit
| 72 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants with skin disease
Infants with healthy skin
Key exclusion criteria
-Subjects with infectious disease
-Subjects who born within 37 weeks gestational-age
-Subjects whos weigh less than 2500 grams at birth
-Subjects whose parents disagree with participating in this study.
-Subjects with other systematic illness (ex. diabetes)
-Subjects with using medicine which effect to sebaceous secretion.(Ex. Retinoid.
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Inoue |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-5785
inoue.takayoshi@kao.com
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Shima |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7530
Homepage URL
shima.kyouko@kao.com
Sponsor or person
Institute
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kac.com
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 11 | 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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 06 | Month | 09 | Day |
Other
Other related information
To identify biological marker which characterize skin disease
Management information
Registered date
| 2019 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042045
