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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028635
Receipt No. R000032774
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 2 (Examination of the seasonal influence)
Date of disclosure of the study information 2017/08/10
Last modified on 2019/04/20

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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 2 (Examination of the seasonal influence)
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 2
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 2 (Examination of the seasonal influence)
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 2
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the seasonal influence about the efficacy 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 Non-randomized
Randomization unit
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.
4.4.Patients who participated in the clinical trial(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);passed more than two months after the examination end.
5.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 10

Research contact person
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
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
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 08 Month 10 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 5
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 08 Month 02 Day
Date of IRB
2017 Year 08 Month 07 Day
Anticipated trial start date
2017 Year 08 Month 14 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 08 Month 10 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=R000032774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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