Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-05 @ 5:42 PM
Study NCT ID:
NCT03645161
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2018-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients', 'timeFrame': '1 year', 'description': 'Compare the results of locally rat and mouse allergen to imported ones.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis Due to Animal Hair and Dander']}, 'descriptionModule': {'briefSummary': 'In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis\n* 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.\n\nExclusion Criteria:\n\n* Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease\n* Patient with allergic asthma who is still uncontrollable.\n* Patient with active severe atopic dermatitis\n* Patient who are pregnant or in lactating period\n* Patient or parent deny to join in the study'}, 'identificationModule': {'nctId': 'NCT03645161', 'briefTitle': 'Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients', 'orgStudyIdInfo': {'id': '789/2560 (EC 2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Local rat and mouse skin test', 'description': 'All patients receive local skin prick test for mouse and rat. The result were recorded and compared to the imported one.', 'interventionNames': ['Diagnostic Test: rat and mouse skin test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Imported rat and mouse skin test', 'description': 'All patients receive imported skin prick test for mouse and rat. The result were recorded and compared to the local one.', 'interventionNames': ['Diagnostic Test: rat and mouse skin test']}], 'interventions': [{'name': 'rat and mouse skin test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients', 'armGroupLabels': ['Imported rat and mouse skin test', 'Local rat and mouse skin test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital. Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Nualanong Visitsunthorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Siriraj hospital, Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nualanong Visitsunthorn', 'investigatorAffiliation': 'Mahidol University'}}}}