UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028395 |
|---|---|
| Receipt number | R000032510 |
| Scientific Title | Effect of anti-immunoglobulin E therapy on chronic prurigo and cholinergic urticaria |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/02/08 09:12:57 |
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Basic information
Public title
Effect of anti-immunoglobulin E therapy on chronic prurigo and cholinergic urticaria
Acronym
Anti-immunoglobulin E therapy on chronic prurigo and cholinergic urticaria
Scientific Title
Effect of anti-immunoglobulin E therapy on chronic prurigo and cholinergic urticaria
Scientific Title:Acronym
Anti-immunoglobulin E therapy on chronic prurigo and cholinergic urticaria
Region
| Japan |
Condition
Condition
urticarial dermatitis, prurigo, cholinergic urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether anti-IgE therapy is effective for chronic prurigo and cholinergic urticaria or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin symptom
blood check
subjective symptom
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Omalizumab 300mg/4weeks, 3times
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who are resistant to the treatments such as topical administration of steroid and orally administration of anti-histamine drugs
Key exclusion criteria
patients orally administrated immune suppressants or high-dose steroid within three months.
patients suffering from severe visceral diseases and mental disorders
patients who is pregnant or breast-feed
patients judged inadequate to this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Pro. Yokozeki |
Organization
Tokyo Medical and Dental University
Division name
Department of Dermatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, 113-8519 Tokyo
TEL
03-5803-5286
3064derm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Ugajin |
Organization
Tokyo Medical and Dental University
Division name
Department of Dermatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, 113-8519 Tokyo
TEL
03-5803-5286
Homepage URL
ugajin.derm@tmd.ac.jp
Sponsor or person
Institute
Department of Dermatology, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical and Dental University Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4575
Tiken.crc@tmd.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
東京医科歯科大学医学部附属病院/ Tokyo Medical and Dental University
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | 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
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 15 | 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 | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032510
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
