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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029024
Receipt No. R000033202
Scientific Title Investigation of covalently bound ceramide in skin diseases
Date of disclosure of the study information 2017/09/06
Last modified on 2020/03/03

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Basic information
Public title Investigation of covalently bound ceramide in skin diseases
Acronym Investigation of covalently bound ceramide in skin diseases
Scientific Title Investigation of covalently bound ceramide in skin diseases
Scientific Title:Acronym Investigation of covalently bound ceramide in skin diseases
Region
Japan

Condition
Condition atopic dermatitis, psoriasis, chronic eczema, asteatotic eczema, senile dry skin, diseases with skin barrier dysfunction
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the relationships between covalently bound ceramide and the pathogenesis of skin disease, or skin barrier function
Basic objectives2 Others
Basic objectives -Others Analyzing the relationships between covalently bound ceramide and the pathogenesis of skin disease, or skin barrier function
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ・covalently bound ceramide
Key secondary outcomes ・free ceramide
・transepidermal water loss
・moisture content of the stratum corneum

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
0 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients giving written informed consent (a substitute in the case of a minor) after receiving sufficient explanation for participation in this research, after sufficient understanding.
2) Patients with skin diseases such as atopic dermatitis (0-50 years), psoriasis (20-60 years), chronic eczema (20-60 years), asteatotic eczema (50 years or older), senile dry skin (50 years or older), or patients with skin barrier dysfunction. As a control, patient without skin barrier dysfunction that matched the generation.
Key exclusion criteria 1) Those who have any skin infectious disease.
2) Those who have a history of contact dermatitis such as dermatitis caused by medical adhesives or mechanic urticaria.
3) Those who have participated in a study involving stratum corneum sampling within 1 month before the study.
4) Those who were determined to be ineligible to participate in this research by the investigators.
Target sample size 380

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Ishiguro
Organization Tokyo Woman's Medical University
Division name Dermatology
Zip code
Address 8-1 Kawada-cho,Shinjyuku-ku,Tokyo 162-8666,Japan
TEL 03-3353-8111
Email ishiguro.naoko@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Ishiguro
Organization Tokyo Woman's Medical University
Division name Dermatology
Zip code
Address 8-1 Kawada-cho,Shinjyuku-ku,Tokyo 162-8666,Japan
TEL 03-3353-8111
Homepage URL
Email ishiguro.naoko@twmu.ac.jp

Sponsor
Institute Tokyo Woman's Medical University
Institute
Department

Funding Source
Organization Meiji 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
Address
Tel
Email

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
2017 Year 09 Month 06 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 31 Day
Date of IRB
2017 Year 08 Month 31 Day
Anticipated trial start date
2017 Year 09 Month 07 Day
Last follow-up date
2019 Year 09 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analyze the relationships between covalently bound ceramide and the pathogenesis of skin disease, or skin barrier function to help decide the necessary treatment.

Management information
Registered date
2017 Year 09 Month 06 Day
Last modified on
2020 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033202

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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