UMIN-CTR Clinical Trial

Basic information
Public title	Double-blind crossover trial to evaluate the efficacy and safety of the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients for atopic dermatitis
Acronym	Double-blind crossover trial to evaluate the efficacy and safety of the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients for atopic dermatitis
Scientific Title	Double-blind crossover trial to evaluate the efficacy and safety of the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients for atopic dermatitis
Scientific Title:Acronym	Double-blind crossover trial to evaluate the efficacy and safety of the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients for atopic dermatitis
Region	Japan

Condition
Condition	atopic dermatitis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients in patients with cholinergic urticaria and atopic dermatitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS for itch
Key secondary outcomes	Subjective symptom(disease questionnaire) Clinical condition(objective symptom: medical examination at the department of dermatology) Total assessment Safety

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients(two weeks)
Interventions/Control_2	the bath additive without sweat-antigen-inactivating and moisturizing ingredients(two weeks)
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with atopic dermatitis, whose treatment is no change within one month. 2.Patients who are 16 years old or older. 3.Patients who can visit our clinic reguraly. 4.Patients who can agree in writing to this study.
Key exclusion criteria	1. Patients who have unstable symptoms. 2. Patients who are treated with oral steroids and/or cyclosporine. 3.Patients who have history of hypersensitivity reactions to bath additive, cosmetics, food or etc. 4.Patients who use a product having the purpose of use like examination bath additive. 5.Patients judged inappropriate for this study by the physicians.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Michihiro Middle name Last name Hide
Organization	Hiroshima University Hospital
Division name	Department of Dermatology
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5238
Email	ed1h-w1de-road@hiroshima-u.ac.jp

Public contact
1st name of contact person	1st name Akiko Middle name Last name Kamegashira
Organization	Hiroshima University, Hiroshima, Japan
Division name	Department of Dermatology
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5238
Homepage URL
Email	kamegash@yahoo.co.jp

Sponsor
Institute	Hiroshima Umiversity Hospital
Institute
Department

Funding Source
Organization	BATHCLIN CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroshima Prefectural Hospital JA Onomichi General Hospital JA Hiroshima General Hospital Tanaka dermatology and allergy clinic Mihara dermatology and allergy clinic Hiroshima City Asa Citizens Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Ethics Review Committee, Hiroshima University
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
Tel	082-257-1576
Email	iryo-seisaku@office.hiroshima-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	2017 Year 02 Month 16 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	34
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	2017 Year 02 Month 16 Day
Date of IRB	2017 Year 02 Month 15 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 10 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2019 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030079