UMIN-CTR Clinical Trial

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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