UMIN-CTR Clinical Trial

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
Email	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
Email	f-sato@qolife.jp

Sponsor
Institute	Takashima Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047051