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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043380
Receipt No. R000048929
Scientific Title Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Date of disclosure of the study information 2021/02/19
Last modified on 2021/02/19

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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 Yakage study
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 and 10% urea cream on skin surface hydration, sebum,basal sweating and disease severity.
Basic objectives2 Others
Basic objectives -Others Bioequivalence assessment based on skin surface hydration, sebum ,basal sweating and disease severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of sebum after application for 1 weeks
Key secondary outcomes Skin surface hydration, basal sweating and severity.

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 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
Email 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 701-0192
Address 577, Matsushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email ymaoyama@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Yakage hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB kawasaki medical school
Address 577, Matsushima, Kurashiki, Okayama, Japan
Tel 086-462-1111
Email 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 川崎医科大学(岡山県)矢掛町国民健康保険病院(岡山県)

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 19 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
2020 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 19 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Monitoring scheduled once every six months

Management information
Registered date
2021 Year 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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