UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042836 |
|---|---|
| Receipt number | R000048902 |
| Scientific Title | Pilot trial of humidity-adjusted charcoal bed for childhood atopic dermatitis with mite allergy |
| Date of disclosure of the study information | 2020/12/24 |
| Last modified on | 2023/06/27 09:04:14 |
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Basic information
Public title
Pilot trial of humidity-adjusted charcoal bed for childhood atopic dermatitis with mite allergy
Acronym
Pilot trial of humidity-adjusted charcoal bed for childhood atopic dermatitis with mite allergy
Scientific Title
Pilot trial of humidity-adjusted charcoal bed for childhood atopic dermatitis with mite allergy
Scientific Title:Acronym
SMU-P HACB-CAD 2019
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Pediatrics | Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For children with atopic dermatitis who have mite allergy, sleeping in a bed laid with humidity control charcoal reduces the number of mites in bedding, and examines the symptoms of atopic dermatitis and the transition of mite allergy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin symptoms; SCRAD score and POEM
Key secondary outcomes
Changes in Bedding Humidity and Temperature
Mite counts in bedding
Relationship between mite counts and housing environment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Research subjects who have a mattress on the bed put humidity control charcoal between the mattress and the bed, and research subjects who have a mattress on the bed put humidity control charcoal between the mattress and the bed on the research start date.
Interventions/Control_2
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
| 6 | months-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Shows "Definition and diagnostic criteria for atopic dermatitis" by the Japanese Dermatological Association.
--Symmetrical eczema with pruritus lasts for 6 months or longer (2 months or longer for babies)
2) The age at the time of consent is 6 months or more and 5 years or less.
3) Positive for specific IgE antibody against Dermatophagoides farinae or Dermatophagoides farinae (0.7 UA / mL or more)
4) Parents have given written consent to participate in the study.
Key exclusion criteria
1) Contact dermatitis, hand eczema, seborrheic dermatitis, cutaneous lymphoma, simple prurigo, psoriasis, psoriasis, immunodeficiency disease, sweat eczema, collagen disease, ichthyosis, Netherton syndrome, sebaceous eczema
2) Receive allergen immunotherapy for mite allergy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Taketani |
Organization
Shimane University
Division name
Department of Pediatrics, Faculty of Medicine
Zip code
693-8501
Address
89-1, Enya, Izumo, Shimane
TEL
0853-20-2220
ttaketani@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Taketani |
Organization
Shimane University
Division name
Department of Pediatrics, Faculty of Medicine
Zip code
693-8501
Address
89-1, Enya, Izumo, Shimane
TEL
0853-20-2220
Homepage URL
ttaketani@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Faculty of Medicine, Shimane University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Shimane University Hospital
Address
89-1, Enya, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2020 | Year | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048902
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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