Back to resultsComparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts
Primary Purpose
Allergy to Arthropod Sting
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Local insect allergen extracts skin test
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergy to Arthropod Sting focused on measuring insect sting allergy, Hymenoptera allergy, local insect allergen extracts
Eligibility Criteria
Inclusion Criteria:
- Patients with severe insect allergy reaction
- Allow being done skin test and blood foe specific IgE
Exclusion Criteria:
- Serious systemic diseases
- severe asthma
- pregnant or nursing
- severe and extended skin lesion
Sites / Locations
- Siriraj hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Skin test with local extract
Skin test with commercial extract
Arm Description
Skin prick test and intradermal test with local stinging insect allergen extracts that develop in Immunological division of Siriraj hospital, mahidol University
Skin prick test and intradermal test with commercial stinging insect allergen extracts that order from ALK company
Outcomes
Primary Outcome Measures
Comparison of positive skin test results of local and commercial insect allergen extracts
Measure wheal size of skin test of local and commercial insect allergen extracts then compare the positive result and wheal size between local and commercial extracts.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03645291
Brief Title
Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts
Official Title
Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts in Patients With Severe Insect Sting Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 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
Comparison the results of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with serious insect sting allergy reactions
Detailed Description
The patients with serious insect sting allergy reactions were evaluated and skin prick test and intradermal test with local and imported insect allergen extracts were performed. Specific IgE for insects was also performed. The results of skin prick testing and Intradermal skin test of local and imported insect allergen extracts were compared. The results also compared with specific IgE to insects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy to Arthropod Sting
Keywords
insect sting allergy, Hymenoptera allergy, local insect allergen extracts
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with severe insect sting allergy
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
None of the patients and participants know the type of insect allergen extracts used in skin prick and intradermal test
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin test with local extract
Arm Type
Active Comparator
Arm Description
Skin prick test and intradermal test with local stinging insect allergen extracts that develop in Immunological division of Siriraj hospital, mahidol University
Arm Title
Skin test with commercial extract
Arm Type
Sham Comparator
Arm Description
Skin prick test and intradermal test with commercial stinging insect allergen extracts that order from ALK company
Intervention Type
Diagnostic Test
Intervention Name(s)
Local insect allergen extracts skin test
Other Intervention Name(s)
commercial insect allergen extracts from ALK skintest
Intervention Description
Every patient received both local and commercial insect allergen extracts but in blinded methods
Primary Outcome Measure Information:
Title
Comparison of positive skin test results of local and commercial insect allergen extracts
Description
Measure wheal size of skin test of local and commercial insect allergen extracts then compare the positive result and wheal size between local and commercial extracts.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with severe insect allergy reaction
Allow being done skin test and blood foe specific IgE
Exclusion Criteria:
Serious systemic diseases
severe asthma
pregnant or nursing
severe and extended skin lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nualanong Visitsunthorn, MD
Organizational Affiliation
Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
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 of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts
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