UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021911 |
|---|---|
| Receipt number | R000025273 |
| Scientific Title | Analysis and comparison of carboxyl esterase and trp channel expression in the skin of sensitive skin persons and atopic dermatitis patients |
| Date of disclosure of the study information | 2016/04/15 |
| Last modified on | 2018/04/10 18:03:57 |
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Basic information
Public title
Analysis and comparison of carboxyl esterase and trp channel expression in the skin of sensitive skin persons and atopic dermatitis patients
Acronym
Analysis and comparison of enzymes in the skin of sensitive skin persons and atopic dermatitis patients
Scientific Title
Analysis and comparison of carboxyl esterase and trp channel expression in the skin of sensitive skin persons and atopic dermatitis patients
Scientific Title:Acronym
Analysis and comparison of enzymes in the skin of sensitive skin persons and atopic dermatitis patients
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis and comparison of carboxyl esterase and trp channel expression in the skin of sensitive skin persons and atopic dermatitis patients
Basic objectives2
Others
Basic objectives -Others
no
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The expression of carboxyl esterase and trp channel
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
skin biopsy
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
The atopic dermatitis patient assumes it the person who had a diagnosis in department of dermatology, Hamamatsu university school of medicine.
We perform questionary survey over a telephone for 800-1000 volunteers about the physically unimpaired person with a sense stimulation sensitive person. We perform stinging examination for 180-190 people in hope of an examination. Based on stinging test result, we choose a subject.
Key exclusion criteria
1. A person with remarkable bleeding tendency.
2. A pregnant woman.
3. The person who has difficulty in self-judgment for dementia.
4. The person whom it was judged a doctor to be in condition to be easy to be accompanied by complications when it enforced skin biopsy.
5. A person during an immunosuppressant, the adrenocorticosteroid whole body dosage.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Tokura |
Organization
Hamamatsu university school of medicine
Division name
Department of dermatology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
053-435-2303
tokura@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Aoshima |
Organization
Hamamatsu university school of medicine
Division name
Department of dermatology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
053-435-2303
Homepage URL
maoshima@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
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
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
浜松医科大学皮膚科（静岡県）、花王株式会社安全性科学研究所、近藤皮膚科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 15 | 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
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 14 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025273
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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