UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048185 |
|---|---|
| Receipt number | R000054055 |
| Scientific Title | Mathematical analysis of spatial and temporal changes in urticaria rash |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2023/06/29 22:51:56 |
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Basic information
Public title
Mathematical analysis of spatial and temporal changes in urticaria rash
Acronym
Mathematical analysis of spatial and temporal changes in urticaria rash
Scientific Title
Mathematical analysis of spatial and temporal changes in urticaria rash
Scientific Title:Acronym
Mathematical analysis of spatial and temporal changes in urticaria rash
Region
| Japan |
Condition
Condition
urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with chronic urticaria, the changes of wheals are photographed over time from their appearance to disappearance, and the morphological changes and morphological patterns of wheals are mathematically analyzed by using the obtained photographic data.
Basic objectives2
Others
Basic objectives -Others
Construction of mathematical model of urticaria rash
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological changes and patterns
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
Acquisition of photographic data of wheals over time.
Discontinuation of oral antihistamines for 3 days prior to study in some patients.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic urticaria who visit the Department of Dermatology, Hiroshima University Hospital, and who meet all of the following selection criteria and none of the exclusion criteria will be eligible for the study.
(1) Patients who are at least 18 years old and not more than 85 years old at the time of obtaining consent.
(2) Patients who can provide written consent for participation in this study.
(3) Patients who have skin rashes almost every day even on treatment or who are expected to have skin rashes every day after discontinuation of treatment.
Key exclusion criteria
Patients deemed inappropriate by the principal investigator or research members
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Takahagi |
Organization
Hiroshima University Hospital
Division name
Dermatology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
TEL
082-257-5555
shunstk@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Matsubara |
Organization
Hiroshima University Hospital
Division name
Dermatology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
TEL
082-257-5555
Homepage URL
daiki523@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
CREST(Core Research for Evolutional Science and Technology)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel
082-257-1947
iryo-seisaku@office.hiroshima-u.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
| 2022 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One case is currently included and under analysis.
Management information
Registered date
| 2022 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054055
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/29 | 蕁麻疹数理モデルの膨疹撮影研究_計画書ver1.1.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
