UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036266 |
|---|---|
| Receipt number | R000041298 |
| Scientific Title | Clinical study of moisturizer on skin physiologic action for asteatosis cutis. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/08/02 10:54:26 |
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Basic information
Public title
Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Acronym
Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Scientific Title
Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Scientific Title:Acronym
Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Region
| Japan |
Condition
Condition
Asteatosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bioequivalence assessment of heparinoid-containing moisturizer versus reference petrolatum based on skin surface hydration, sebum and disease severity.
Basic objectives2
Others
Basic objectives -Others
Bioequivalence assessment based on skin surface hydration, sebum and disease severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of sebum after application for 2 weeks
Key secondary outcomes
Skin surface hydration, severity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Moisturizer
Interventions/Control_2
14 days
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
1.Person older than 20years. 2 .Person who agree to participate in this trial. 3 Person with asteatosis.
Key exclusion criteria
1.Patient with iching due to other than dry skin.
2.Patient with skin ulcer or erosion at the site.
3.Person who has hypersensitivity for moisturizer and base.
4 Person who enrolled in other cclinical trial within a month.
5 Person who was disqualified by prin cipal clinician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Aoyama |
Organization
Kawasaki Medical School
Division name
Dermatology
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
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
Dermatology
Zip code
700-0192
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
Homepage URL
ymaoyama@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yakage Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
abc
Address
577, Matsushima, Kurashiki, Okayama, Japan
Tel
086-462-1111
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
| 2019 | Year | 04 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041298
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
