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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040220 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Atopic dermatitis | |
Classification by specialty |
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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.
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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 |
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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. |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |