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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026576
Receipt No. R000025775
Scientific Title Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Date of disclosure of the study information 2017/04/01
Last modified on 2019/04/23

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Basic information
Public title Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Acronym Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Scientific Title Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Scientific Title:Acronym Comparison of the effects of moisturizer and steroid ointment on water content of stratum corneum and skin surface morphology.
Region
Japan

Condition
Condition healthy control and atopic dermatitis
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of sweating response and skin structure associated with heparinoid containing moisturizer and steroid ointment.
Basic objectives2 Others
Basic objectives -Others sweating response and alternation of skin folds.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Status of sweating after application for 2 weeks.
Key secondary outcomes Skin surface hydration, texture of skin.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 moisturizer and base.
Interventions/Control_2 7 days and 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 20yo.
2.Person who agree to participate in this trial.
3.Healthy person or patient with AD.
Key exclusion criteria 1.Person with allergic dermatitis.
2.Person with sweat disturbance.
3.Person who has hypersensitivity for moisturizer and base.
4.Person who enrolled in other clinical trial within a month.
5.Person who was disqualified by principal clinician.
Target sample size 30

Research contact person
Name of lead principal investigator
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 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 Hospital
Division name Department of Dermatology
Zip code 700-0192
Address 2-1-80, Nakasannge, Kitaku, Okayama, Japan
TEL 086-225-2111
Homepage URL
Email kmsrec@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical Center, Kawasaki Medical School
Institute
Department

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

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

IRB Contact (For public release)
Organization Research ethics committee of kawasaki medical school and hospital
Address 577, Matsushima, Kurashiki, Okayama, Japan
Tel 086-462-1111
Email ymaoyama@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 川崎医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2017 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 29 Day
Date of IRB
2016 Year 03 Month 29 Day
Anticipated trial start date
2016 Year 03 Month 29 Day
Last follow-up date
2020 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 16 Day
Last modified on
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025775

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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