UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048141 |
|---|---|
| Receipt number | R000054733 |
| Scientific Title | Elucidation of molecular pathogenesis of atopic dermatitis |
| Date of disclosure of the study information | 2022/06/24 |
| Last modified on | 2022/12/22 16:22:06 |
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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
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
yoshiki-kubota@nanoegg.co.jp
Sponsor or person
Institute
NANOEGG Research Laboratories, Inc.
Institute
Department
Personal name
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
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
Completed
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 | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054733
