UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053784 |
|---|---|
| Receipt number | R000060988 |
| Scientific Title | Efficacy of intradermal immunotherapy using maximum intradermally tolerated dose to pet (cats and dogs) allergies. |
| Date of disclosure of the study information | 2024/03/10 |
| Last modified on | 2024/03/05 18:54:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of intradermal immunotherapy to pet (cats and dogs) allergies.
Acronym
IDIT-PETALS
Scientific Title
Efficacy of intradermal immunotherapy using maximum intradermally tolerated dose to pet (cats and dogs) allergies.
Scientific Title:Acronym
MITD-IDIT PETALS
Region
| Japan |
Condition
Condition
pet (dogs and cats) allergies
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of intradermal immunotherapy for various allergic symptoms (allergic rhinoconjunctivitis, atopic dermatitis, urticaria, bronchial asthma, atopic cough) to pets (cats and dogs) will be investigated to explore the development of a new device using a microneedle patch that can reach the skin dermis. This intradermal immunotherapy uses an individual-specific maximum intradermally tolerated dose (MITD).
1. to check the degree of improvement of symptoms caused by the pet by means of a questionnaire (subjective index).
2. to examine efficacy and safety by objective indices.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in severity of each symptom by pet before and after treatment using visual analogue scale (VAS).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 5 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who meet any of the following: positive specific IgE antibody values, positive skin prick test which shows wheal 4mm or more compared to the negative control, positive intradermal test which shows wheal diameter expansion of 2mm or more.
2.Those for whom conventional medication, such as oral anti-allergic agents, topical drugs, and inhalants, is insufficient.
Key exclusion criteria
1.individuals currently using beta-blockers, calcium channel blockers, antidepressants, other psychiatric drugs, anti-IgE antibodies, biologics, cytokine receptor antibodies, immunosuppressants, or oral steroids as treatment.
2.Individuals who are pregnant or may be pregnant.
3.Individuals undergoing treatment for or suspected of having malignant neoplasms.
4.Individuals with a history of fatal anaphylaxis or angioedema.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | kyoko |
| Middle name | S |
| Last name | nishikage |
Organization
Yokohama-Nishikage clinic, kids and allergies
Division name
medical department
Zip code
221-0834
Address
15-1 Daimachi, Kanagawaku, Yokohama city, Kanagawa prefecture
TEL
0453235115
kyoko@yokohama-nishikage.clinic
Public contact
Name of contact person
| 1st name | kyoko |
| Middle name | S |
| Last name | nishikage |
Organization
Yokohama-Nishikage clinic, kids and allergies
Division name
medical department
Zip code
2210834
Address
15-1 Daimachi, Kanagawaku, Yokohama city, Kanagawa prefecture
TEL
0453235115
Homepage URL
kyoko@yokohama-nishikage.clinic
Sponsor or person
Institute
Yokohama-Nishikage clinic, kids and allergies
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Non-profit Organization Tokyo Allergy and Respiratory Disease Research Institute
Address
Riverside Tower 3F, 1-8-6 Kuramae,
Tel
07038943785
takahiro.chisaki@inclusion-p.com
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
| 2024 | Year | 03 | Month | 10 | 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
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"Methods"
Intradermal immunotherapy will be administered based on the physician's judgment that it is the optimal treatment for each individual patient, following the patient's wishes and written consent. This will be an observational study tracking test results and questionnaire outcomes over the course of treatment.
If there is a group that has chosen desensitization therapy for the same allergen or causative substance, retrospectively compare and evaluate the effectiveness, immediacy, and safety of the treatment.
Personalized intradermal immunotherapy method: Conduct skin tests using a solution that has been progressively diluted fivefold from the allergen solution at the prick-negative threshold and inject intradermally twice a week the highest concentration solution that does not provoke skin reactions (redness and swelling) or systematic reactions. The treatment dose is called MITD (maximum intradermally tolerated dose ). The MITD is specific to the individual and the target allergen. The treatment period is initially 24 weeks (with treatments twice a week) and then up to 48 weeks (with treatments once a week) but will be set individually based on the degree of symptom improvement and test results. The progress will be recorded regularly in both electronic and paper medical records using symptom records and standardized questionnaires.
Management information
Registered date
| 2024 | Year | 03 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060988
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
