UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037466
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email takada.naoto@kao.com

Sponsor
Institute Kao Corporation
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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9220
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042712

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.