UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047190 |
|---|---|
| Receipt number | R000053830 |
| Scientific Title | Quantification of skin hardness of patients with systemic scleroderma using a SOFTGRAM |
| Date of disclosure of the study information | 2022/03/17 |
| Last modified on | 2023/09/26 01:30:48 |
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Basic information
Public title
Quantification of skin hardness of patients with systemic scleroderma using a SOFTGRAM
Acronym
Quantification of skin hardness of patients with systemic scleroderma using a SOFTGRAM
Scientific Title
Quantification of skin hardness of patients with systemic scleroderma using a SOFTGRAM
Scientific Title:Acronym
Quantification of skin hardness of patients with systemic scleroderma using a SOFTGRAM
Region
| Japan |
Condition
Condition
Systemic scleroderma
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating a correlation between elastic modulus with a SOFTGRAM and modified Rodnan skin score
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between elastic modulus with a SOFTGRAM and modified Rodnan skin score
Key secondary outcomes
Comparing elastic modulus with a SOFTGRAM between patients of systemic scleroderma and those who are not
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of systemic scleroderma and those who are not
Key exclusion criteria
A person who is judged inappropriate for participating in the study by a doctor
A person who have skin lesions in the part for evaluation except the skin lesions of systemic scleroderma
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiraku |
| Middle name | |
| Last name | Kokubu |
Organization
Shiga University of Medical Science
Division name
Department of Dermatology
Zip code
5202192
Address
Seta Tsukinowa, Otsu, Shiga, Japan
TEL
077-548-2233
kokubu@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiraku |
| Middle name | |
| Last name | Kokubu |
Organization
Shiga University of Medical Science
Division name
Department of Dermatology
Zip code
520-2192
Address
Seta Tsukinowa, Otsu, Shiga, Japan
TEL
0775482233
Homepage URL
kokubu@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Dermatology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
ISHIDA MEDICAL CO.,LTD.
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
Shiga University of Medical Science Research Ethics Committee.
Address
Seta Tsukinowa, Otsu, Shiga, Japan
Tel
077-548-3576
hqrec@belle.shiga-med.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
滋賀医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 17 | 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
| 2021 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 26 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 26 | Day |
Other
Other related information
Elastic modulus and modified Rodnan's total skin thickness score in the eight parts below
Outside forearms
Midpoint between proximal interphalangeal joint and metacarpophalangeal joint of the middle fingers
Radial fossas on back of the hands
Midpoint between malar archs and mental region
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053830
