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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021911
Receipt No. 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

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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
Email 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
Email maoshima@hama-med.ac.jp

Sponsor
Institute Hamamatsu university school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025273

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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