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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048141
Receipt No. R000054733
Scientific Title Elucidation of molecular pathogenesis of atopic dermatitis
Date of disclosure of the study information 2022/06/24
Last modified on 2022/06/22

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Basic information
Public title Elucidation of molecular pathogenesis of atopic dermatitis
Acronym Elucidation of molecular pathogenesis of atopic dermatitis
Scientific Title Elucidation of molecular pathogenesis of atopic dermatitis
Scientific Title:Acronym Elucidation of molecular pathogenesis of atopic dermatitis
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparative analysis of endogenous signaling molecule-related factors in skin tissue derived from atopic dermatitis patients and healthy subjects
Basic objectives2 Others
Basic objectives -Others Tissue analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immunohistological and biochemical analysis
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria [AD patient]
1) Individuals who have been diagnosed with AD according to Hanifin & Rajika's atopic dermatitis diagnostic criteria
2) Individuals who can visit to clinic (Japanese males or females)
3) Individuals providing written informed consent
4) Individuals not younger than 18 years old at the time of informed consent

[Healthy subject]
1) Individuals who do not have skin diseases
2) Individuals who can visit to clinic (Japanese males or females)
3) Individuals providing written informed consent
4) Individuals not younger than 18 years old at the time of informed consent
Key exclusion criteria 1) Individuals who are judged to be prone to complications by skin biopsy
2) Individuals who are or are possibly pregnant, or are lactating
3) Individuals who have severe skin diseases other than AD
4) Individuals who have difficulty with anesthetics or who have experienced illness due to anesthetics
5) Individuals without capacity to consent
6) Individuals judged inappropriate for the study by a doctor
Target sample size 11

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Yamaguchi
Organization NANOEGG Research Laboratories, Inc.
Division name Pharmaceutical Products Research and Development Section
Zip code 210-0821
Address Innovation Center of NanoMedicine 4F, 3-25-14 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL 044-400-1155
Email rdm@nanoegg.co.jp

Public contact
Name of contact person
1st name Yoshiki
Middle name
Last name Kubota
Organization NANOEGG Research Laboratories, Inc.
Division name Pharmaceutical Products Research and Development Section
Zip code 210-0821
Address Innovation Center of NanoMedicine 4F, 3-25-14 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL 044-400-1155
Homepage URL
Email yoshiki-kubota@nanoegg.co.jp

Sponsor
Institute NANOEGG Research Laboratories, Inc.
Institute
Department

Funding Source
Organization NANOEGG Research Laboratories, Inc.
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 Asai Dermatology Clinical Trial Review Committee Secretariat
Address 3-4-8 Hatchobori, Chuo-ku, Tokyo
Tel 03-5543-0196
Email chiho.tamura@smo-msr.co.jp

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

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 24 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 Preinitiation
Date of protocol fixation
2022 Year 06 Month 07 Day
Date of IRB
2022 Year 06 Month 20 Day
Anticipated trial start date
2022 Year 06 Month 24 Day
Last follow-up date
2023 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational studies with invasiveness (skin biopsy)

Management information
Registered date
2022 Year 06 Month 23 Day
Last modified on
2022 Year 06 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054733

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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