UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029044 |
|---|---|
| Receipt number | R000033178 |
| Scientific Title | The study on effectiveness of sublingual immunotherapy with mite extract in patients with atopic dermatitis |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/09/09 13:41:52 |
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Basic information
Public title
The study on effectiveness of sublingual immunotherapy with mite extract in patients with atopic dermatitis
Acronym
Effectiveness of sublingual immunotherapy with mite extract in patients with atopic dermatitis
Scientific Title
The study on effectiveness of sublingual immunotherapy with mite extract in patients with atopic dermatitis
Scientific Title:Acronym
Effectiveness of sublingual immunotherapy with mite extract in patients with atopic dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of sublingual immunotherapy on symptom improvement in patients with atopic dermatitis which have perennial allergic rhinitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eczema Area and Severity Index score (1,3,6,12,18,24 months after initiation of sublingual immunotherapy)
Key secondary outcomes
skin test, specific IgE, serum TARC, itchy severity index (VAS), Nasal symptom score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sublingual tablet for house dust mite 3,300 JAU was selected as the initial dose for a week, followed by upward titration of the dose to 10,000 JAU, and continue for 2 years
Interventions/Control_2
Non-intervention
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Symptom of rhinitis on medical history
(2) Upper than 5 in EASI score
(3) Patients with positive skin test and specific IgE antibody for house dust mite
(4) Patients who agree with this examination
(5) Older than 20 years
Key exclusion criteria
(1) Pregnant and breast-feeding patients
(2) Patients with severe asthma
(3) Patients who take oral corticosteroid and cyclosporine
(4) Inappropriate patients in this examination
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Chikako |
| Middle name | |
| Last name | Nishigori |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Dermatology, Department of Internal Related
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-6134
chikako@ed.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Mizuno |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Dermatology, Department of Internal Related
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-6134
Homepage URL
196m858m@stu.kobe-u.ac.jp
Sponsor or person
Institute
Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
The Ethics Committee at Kobe University Hospital
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel
078-382-6669
kainyu@med.kobe-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
| 2019 | Year | 04 | Month | 01 | 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
12
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
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 07 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033178
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/05/10 | 研究計画書20180313.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
