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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029044
Receipt No. 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 2019/05/10

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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
Email chikako@ed.kobe-u.ac.jp

Public contact
Name of contact person
1st name Ai
Middle name
Last name Yoshioka
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
Email aiichi39@gmail.com

Sponsor
Institute Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine
Institute
Department

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
Email 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 10
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
2023 Year 12 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
2017 Year 09 Month 07 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.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


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