UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026182 |
|---|---|
| Receipt number | R000030079 |
| 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 |
| Date of disclosure of the study information | 2017/02/16 |
| Last modified on | 2019/04/20 00:09:00 |
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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
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
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
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
kamegash@yahoo.co.jp
Sponsor or person
Institute
Hiroshima Umiversity Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030079
