UMIN-CTR Clinical Trial

Basic information
Public title	The effect of natural mineral dissolved water on the skin in atopic dermatitis
Acronym	The effect of natural mineral dissolved water on the skin in atopic dermatitis
Scientific Title	The effect of natural mineral dissolved water on the skin in atopic dermatitis
Scientific Title:Acronym	The effect of natural mineral dissolved water on the skin in atopic dermatitis
Region	Japan

Condition
Condition	Atopic dermatitis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate the effects of natural mineral dissolved water on the skin in atopic dermatitis. Clinical symptoms, skin moisture content will be examined.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical Score (SCORAD, EASI, IGA) at day1, 14 and 28.
Key secondary outcomes	Transepidermal water transpiration and stratum corneum water contentat day 0, 14 and 28. Correlation between clinical scores and transepidermal water transpiration and stratum corneum water content.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Two consecutive weeks of bathing with tap water followed by two consecutive weeks of bathing with natural mineral dissolved water. The patients will visit hospital at days 1, 14 and 28 to measure clinical scores and transepidermal water transpiration and stratum corneum water content using the DermaLab Combo.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Mild atopic dermatitis (EASI socore, less than 16 points) Equal ratio of men to women Outpatient clinic Patients with no change in atopic dermatitis morbidity (no change in topical or medication) in the month prior to the start of the study
Key exclusion criteria	Patients who are unable to take bathe for 28 consecutive days during the study Patients with prominent skin erosions and ulcers due to atopic dermatitis
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Seiichiro Middle name Last name Motegi
Organization	Gunma University Hospital
Division name	Department of Dermatology
Zip code	371-8511
Address	3-39-15, Showa, Maebashi, Gunma
TEL	0272208284
Email	smotegi@gunma-u.ac.jp

Public contact
Name of contact person	1st name Akihiko Middle name Last name Uchiyama
Organization	Gunma University Hospital
Division name	Department of Dermatology
Zip code	371-8511
Address	3-39-15, Showa, Maebashi, Gunma
TEL	0272208284
Homepage URL
Email	akihiko1016@gunma-u.ac.jp

Sponsor
Institute	Department of Dermatology, Gunma University Hospital
Institute
Department

Funding Source
Organization	Yamato 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	Gunma University Hospital, Department of clinical trial
Address	3-39-15, Showa, Maebashi, Gunma
Tel	0272208747
Email	hitotaisho-ciru@ml.gunma-u.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	2020 Year 04 Month 27 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 04 Month 22 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 22 Day
Last modified on	2020 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045876

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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