UMIN-CTR Clinical Trial

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 Yumi Middle name Last name Aoyama
Organization	Department of dermatology, Kawasaki Medical School
Division name	Dermatology
Zip code	701-0192
Address	086-462-1111
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	Department of dermatology, Kawasaki Medical School, 577 Matsushima Kurashiki city, Okayama Japan
Division name	Dermatology
Zip code	701-0192
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	Kawasaki Medical School
Address	577 Matsushima Kurashiki 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

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 10 Month 23 Day

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