UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026052
Receipt No. R000029305
Scientific Title Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Date of disclosure of the study information 2017/03/01
Last modified on 2019/03/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Acronym Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Scientific Title Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Scientific Title:Acronym Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Region
Japan

Condition
Condition asteatotic eczema
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 comparative testing of Steroid ointment and steroid ointment+moisturizer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes disease severity after application for 2weeks.
Key secondary outcomes itching score, skin surface hydration, sweating, 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 Active
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 steroid ointment and steroid containing moisturizer
Interventions/Control_2 7days 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 Older than 20yo.
agree to participate in this trial.
person with asteatotic eczema distributed symmetrically.
Key exclusion criteria Person with allergic dermatitis other than asteatotic eczema.
Person with bacterial skin infection.
Sever atopic dermatitis patient.
Person who has hypersensitivity for steroid or steroid containing moisturizer
Person who enrolled in other clinical trial within a month.
Person who was disqualified by principal clinician.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumi Aoyama
Organization Department of dermatology, Kawasaki Medical School
Division name Dermatology
Zip code
Address 086-462-1111
TEL 086-462-1111
Email ymaoyama@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Aoyama
Organization Department of dermatology, Kawasaki Medical School, 577 Matsushima Kurashiki city, Okayama Japan
Division name Dermatology
Zip code
Address 086-462-1111
TEL 086-462-1111
Homepage URL
Email kmsrec@med.kawasaki-m.ac.jp

Sponsor
Institute Department of dermatology, Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
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 03 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
2017 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 24 Day
Last follow-up date
2017 Year 12 Month 20 Day
Date of closure to data entry
2018 Year 02 Month 22 Day
Date trial data considered complete
2018 Year 02 Month 22 Day
Date analysis concluded
2019 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 08 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.