UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041204 |
|---|---|
| Receipt number | R000047051 |
| Scientific Title | Observation of atopic dermatitis in high-performance shower heads with a general shower head as a control Double-blind randomized trial |
| Date of disclosure of the study information | 2020/07/24 |
| Last modified on | 2021/01/13 16:57:42 |
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Basic information
Public title
Observation of atopic dermatitis in high-performance shower heads with a general shower head as a control Double-blind randomized trial
Acronym
Observation of atopic dermatitis in high-performance shower heads with a general shower head as a control Double-blind randomized trial
Scientific Title
Observation of atopic dermatitis in high-performance shower heads with a general shower head as a control Double-blind randomized trial
Scientific Title:Acronym
Observation of atopic dermatitis in high-performance shower heads with a general shower head as a control Double-blind randomized trial
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the improvement of atopic dermatitis after using a high performance shower head for 12 weeks with general shower head
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation prescribed in "Atopic Dermatitis Practice Guideline 2018" established by the Japanese Dermatological Association
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High performance shower head
Interventions/Control_2
General shower head
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Men and women over the age of 18 diagnosed with atopic dermatitis
2) Those who can only use the shower during the test period
3) Those who have agreed to take a picture of the affected area
4) Those who can install the shower head specified in the test
5) Can obtain written consent
Key exclusion criteria
1) There are skin diseases other than atopic dermatitis such as burns
2) With tattoos and tattoos
3) May become pregnant during pregnancy or during the study period
4) Heart disease, cerebrovascular disease, arrhythmia, history of dizziness and being affected
5) Systolic blood pressure at screening is 170 mmHg or more or diastolic blood pressure is 110 mmHg or more. However, those taking antihypertensive drugs have systolic blood pressure of 150 mmHg or more.
6) May be in need of treatment during treatment or for malignant tumor
7) Surgical operation was performed within 6 months from the time of screening, or radiotherapy for malignant tumor.
8) The investigator determined that he was unsuitable as a researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Takashima |
Organization
Takashima Clinic
Division name
Critical Research
Zip code
5560011
Address
1-13-2, Namba-naka, naniwa-ku, Osaka
TEL
06-6606-9090
f-sato@qolife.jp
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Sato |
Organization
Takashima Clinic
Division name
Critical Research
Zip code
5560011
Address
1-13-2, Namba-naka, naniwa-ku, Osaka
TEL
06-6606-9090
Homepage URL
f-sato@qolife.jp
Sponsor or person
Institute
Takashima Clinic
Institute
Department
Personal name
Funding Source
Organization
Science, 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
Takashima Clinic Ethics Committee
Address
1-13-2, Namba-naka, naniwa-ku, Osaka
Tel
06-6606-9090
f-sato@qolife.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 | 07 | Month | 24 | 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
57
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
| 2020 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 12 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047051
