UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037466 |
|---|---|
| Receipt number | R000042712 |
| Scientific Title | Analysis of time dependency of skin molecules on atopic dermatitis. |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2020/01/22 17:20:01 |
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Basic information
Public title
Analysis of time dependency of skin molecules on atopic dermatitis.
Acronym
Analysis of time dependency of skin molecules on atopic dermatitis.
Scientific Title
Analysis of time dependency of skin molecules on atopic dermatitis.
Scientific Title:Acronym
Analysis of time dependency of skin molecules on atopic dermatitis.
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the time dependency of skin molecules on atopic dermatitis.
Basic objectives2
Others
Basic objectives -Others
The observational study the relationship between skin molecules and status of atopic dermatitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze the time dependency of skin molecules on atopic dermatitis.
Key secondary outcomes
To analyze the contents and the time dependency of skin molecules between healthy subjects and atopic dermatitis.
To analyze relationships between some disease conditions and skin molecules
To analyze relationships between skin molecules and questionnaires.
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males,
1. who are 20-59 years old
2. with normal BMI (18.5-25.0)
3. regularly shaving faces
4. who are able to attend at the designated days
5. who have been given informed consent
6. who researchers or doctors assess are suitable for entry
AD patients,
in addition to above 1-6,
7. who have light or medium class atopic dermatitis.
Key exclusion criteria
Healthy males,
1. who have experienced dermatosis such as atopic dermatitis, psoriasis, ichthyosis, cutaneous lymphoma or severe acnes
2. who have experienced allergic diseases such as asthma, rhinitis, conjunctivitis, drug allergy
3. who have used antibiotics within 2weeks
4. who have suffered from some diseases possible to affect the study within 1month
5. who have infected with HBV, HCV, HIV or syphilis virus
6. using some medicines possible to affect the study within 1month
7. who have severe sunburn on areas of interest
8. who have experienced cosmetic dermatologic surgery on areas of interest
9. who disagree with blood collection
10. attending any other clinical studies
11. regularly smoking
12. attending to advertising agency, consulting company, mass media, transportation, drug or cosmetic industry
13. who researchers or doctors assess are not suitable for entry
AD patients,
in addition to above 3 - 13,
14. who have experienced dermatosis such as psoriasis, ichthyosis, cutaneous lymphoma or severe acnes except for atopic dermatitis
15. applying steroids or immunosuppressant on faces over 15days in a month.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Inoue |
Organization
Kao Corporation
Division name
R&D Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7530
inoue.takayoshi@kao.com
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Takada |
Organization
Kao Corporation
Division name
R&D Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7888
Homepage URL
takada.naoto@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@kao.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
株式会社インフォワード（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | 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
60
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 | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze the time dependency of skin molecules on atopic dermatitis.
Management information
Registered date
| 2019 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042712
