UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049789 |
|---|---|
| Receipt number | R000056574 |
| Scientific Title | AAAMS study |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2023/10/16 11:43:52 |
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Basic information
Public title
Study on the pathogenesis of asteatosis and asteatotic eczema associated with the sweating function
Acronym
AAAMS study
Scientific Title
AAAMS study
Scientific Title:Acronym
AAAMS study
Region
| Japan |
Condition
Condition
asteatosis
asteatosis eczema
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the presence or absence for sweating disorders in patients with asteatosis and asteatosis eczema..
Basic objectives2
Others
Basic objectives -Others
To study the relationship between basal sweating, microvascular structure and blood volume in patients with asteatosis and asteatosis eczema. And to investigate the water content of the stratum corneum, sebum,
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of basal sweating on lower legs in healthy subjects and patients (before treatment)
Key secondary outcomes
The difference of microvascular structure, blood volume , the water content of the stratum corneum, sebum and overall dry skin score of the lower legs in healthy subjects and patients (before treatment).
Changes over time of basal sweating, blood volume, microvascular structure, the water content of the stratum corneum, sebum, overall dry skin score and pruritus NRS of the lower legs in patients after treatment.
Changes over time in basal sweating, blood volume, microvascular structure, sebum, the water content of the stratum corneum, overall dry skin score and pruritus NRS of the lower legs after treatment by difference of topical application in patients.
Cluster classification based on 3 axes: number of sweating drops on the ridge, number of sweating drops in the fold, and skin microstructure.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Measurement of blood volume and microvascular structure by RSOM
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 with asteatosis or asteatosis eczema who have skin symptom at the lower legs and are 30 years or older
Key exclusion criteria
Patients who have used any topical preparation (including over-the-counter drugs, quasi-drugs, or cosmetics) on their lower leg within 7 days preceding the visit
Patients who are using medication for diabetes treatment or are on dialysis
Patients who are using anticancer drugs
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | YUMI |
| Middle name | |
| Last name | AOYAMA |
Organization
Kawasaki Medical Schoo
Division name
Department of Dermatology
Zip code
701-0192
Address
577,Matsushima,Kurashiki,Okayama,Japan
TEL
0864621111
ymaoyama@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | YUMI |
| Middle name | |
| Last name | AOYAMA |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
701-0192
Address
577,Matsushima,Kurashiki,Okayama,Japan
TEL
0864621111
Homepage URL
kmsrec@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Marino Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Hiroshima University Research Institute for Nanodevice
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School Ethics Review Board
Address
577,Matsushima,Kurashiki,Okayama,Japan
Tel
0864621111
kmsrec@med.kawasaki-m.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
| 2023 | Year | 01 | Month | 31 | 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 | 12 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056574
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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