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Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts

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ClinicalTrials.gov Identifier: NCT03645161
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University

Brief Summary:
In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Due to Animal Hair and Dander Diagnostic Test: rat and mouse skin test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients
Actual Study Start Date : May 30, 2018
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Local rat and mouse skin test
All patients receive local skin prick test for mouse and rat. The result were recorded and compared to the imported one.
Diagnostic Test: rat and mouse skin test
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients

Active Comparator: Imported rat and mouse skin test
All patients receive imported skin prick test for mouse and rat. The result were recorded and compared to the local one.
Diagnostic Test: rat and mouse skin test
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients




Primary Outcome Measures :
  1. Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients [ Time Frame: 1 year ]
    Compare the results of locally rat and mouse allergen to imported ones.



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Ages Eligible for Study:   3 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645161


Locations
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Thailand
Siriraj Hospital. Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nualanong Visitsunthorn, MD Department of Pediatrics, Siriraj hospital, Mahidol University

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Responsible Party: Nualanong Visitsunthorn, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT03645161     History of Changes
Other Study ID Numbers: 789/2560 (EC 2)
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases