UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046366 |
|---|---|
| Receipt number | R000052901 |
| Scientific Title | An open label single group study to investigate the effect of granular ceramic treated water with ELCE (R) showerhead on dry skin. |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2023/07/18 15:45:15 |
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Basic information
Public title
An open label single group study to investigate the effect of granular ceramic treated water with ELCE (R) showerhead on dry skin.
Acronym
Clinical trial to investigate the effect of granular ceramic treated water with ELCE (R) showerhead on dry skin.
Scientific Title
An open label single group study to investigate the effect of granular ceramic treated water with ELCE (R) showerhead on dry skin.
Scientific Title:Acronym
Clinical trial to investigate the effect of granular ceramic treated water with ELCE (R) showerhead on dry skin.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of granular ceramic treated water with ELCE (R) showerhead on dry skin improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS evaluation of "skin hydration" for subjective skin condition assessment after 8 weeks of using the ELCE (R) showerhead.
Key secondary outcomes
1. VAS evaluation of subjective skin conditions other than "skin hydration".
2. Satisfaction with the use of the ELCE (R) showerhead.
3. Percutaneous moisture evaporation.
4. Stratum corneum moisture content.
5. Adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use the ELCE (R) showerhead for 8 weeks.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who have symptom of dry skin.
3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects who answered in the self-reported health questionnaire that they currently have a skin disease that requires treatment.
2. Subjects who answered in the self-reported health questionnaire that they have had or are currently suffering from respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease that requires hospital treatment.
3. Subjects who had a serious injury or surgical history within 12 weeks prior to this study.
4. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence.
5. Subjects who are undergoing special facial care (e.g. facial appliances, aesthetic treatments, peels, laser treatments, etc.) which would affect this study.
6. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study.
7. Subjects who have cognitive disorder or who have possibility of the disorder.
8. Subjects who participated and took the study drug in other clinical trials within four weeks prior to this study.
9. Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Health-Care Research Department of the University Hospital's Kiyotake Satellite Branch, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Health-Care Research Department, University of Miyazaki
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
| 2021 | Year | 12 | Month | 20 | 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
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 13 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052901
