UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040220 |
|---|---|
| Receipt number | R000045876 |
| Scientific Title | The effect of natural mineral dissolved water on the skin in atopic dermatitis |
| Date of disclosure of the study information | 2020/04/27 |
| Last modified on | 2020/05/13 20:09:22 |
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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
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
akihiko1016@gunma-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Gunma University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045876
