UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056393 |
|---|---|
| Receipt number | R000064431 |
| Scientific Title | Exosomal changes in psychosomatic approach to psychosomatic-prone atopic dermatitis |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2024/12/08 14:33:15 |
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Basic information
Public title
Exosomal changes in psychosomatic approach to psychosomatic-prone atopic dermatitis
Acronym
Exosomal changes in psychosomatic approach
Scientific Title
Exosomal changes in psychosomatic approach to psychosomatic-prone atopic dermatitis
Scientific Title:Acronym
Exosomal changes in psychosomatic approach
Region
| Japan |
Condition
Condition
psychosomatic-prone atopic dermatitis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore the potential of serum exosomes as biomarkers for the treatment of stress-related diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of microarray profiles contained by serum exosomes before and after initial psychosomatic approach treatment
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Psychosomatic approach
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
Patients with atopic dermatitis who meet the definition of psychosomatic disease
Key exclusion criteria
Patients with non-communicative psychiatric disorders such as cognitive dysfunction
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5731010
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
TEL
0728040101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
TEL
0728040101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
Tel
0728040101
hasuohid@hirakata.kmu.ac.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
| 2025 | Year | 03 | 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
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
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064431
