Back to resultsComparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
Primary Purpose
Allergic Rhinitis Due to Animal Hair and Dander
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
rat and mouse skin test
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergic Rhinitis Due to Animal Hair and Dander
Eligibility Criteria
Inclusion Criteria:
- Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis
- Patient must not take these following medication at least 7 days before doing the skin prick test: antihistamine, oral corticosteroid (more than 20 mg/day of prednisolone), topical steroid that was apply on skin test area.
Exclusion Criteria:
- Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease
- Patient with allergic asthma who is still uncontrollable.
- Patient with active severe atopic dermatitis
- Patient who are pregnant or in lactating period
- Patient or parent deny to join in the study
Sites / Locations
- Siriraj Hospital. Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Local rat and mouse skin test
Imported rat and mouse skin test
Arm Description
All patients receive local skin prick test for mouse and rat. The result were recorded and compared to the imported one.
All patients receive imported skin prick test for mouse and rat. The result were recorded and compared to the local one.
Outcomes
Primary Outcome Measures
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
Compare the results of locally rat and mouse allergen to imported ones.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03645161
Brief Title
Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
Official Title
Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones
Detailed Description
Many researches proposed that rodent deteriorate symptoms in patients with respiratory allergy who sensitized. The test that can identify rodent sensitization will be very useful. The investigators found lots of problems from imported mouse and rat allergen extract, eg. expensive cost and hard to find importing agency in Thailand. Making own local allergen extract will be the good solution for the country. This study aim to compare the results of locally rat and mouse allergen to imported ones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis Due to Animal Hair and Dander
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local rat and mouse skin test
Arm Type
Active Comparator
Arm Description
All patients receive local skin prick test for mouse and rat. The result were recorded and compared to the imported one.
Arm Title
Imported rat and mouse skin test
Arm Type
Active Comparator
Arm Description
All patients receive imported skin prick test for mouse and rat. The result were recorded and compared to the local one.
Intervention Type
Diagnostic Test
Intervention Name(s)
rat and mouse skin test
Intervention Description
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
Primary Outcome Measure Information:
Title
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
Description
Compare the results of locally rat and mouse allergen to imported ones.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis
Patient must not take these following medication at least 7 days before doing the skin prick test: antihistamine, oral corticosteroid (more than 20 mg/day of prednisolone), topical steroid that was apply on skin test area.
Exclusion Criteria:
Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease
Patient with allergic asthma who is still uncontrollable.
Patient with active severe atopic dermatitis
Patient who are pregnant or in lactating period
Patient or parent deny to join in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nualanong Visitsunthorn, MD
Organizational Affiliation
Department of Pediatrics, Siriraj hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital. Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
publication
Learn more about this trial
Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
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