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Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT03645291
Collaborator
(none)
27
Enrollment
1
Location
2
Arms
13.3
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Local insect allergen extracts skin test
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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 allergyComparison of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with severe insect sting allergy
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
None of the patients and participants know the type of insect allergen extracts used in skin prick and intradermal test
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jun 20, 2018
Actual Primary Completion Date :
May 30, 2019
Actual Study Completion Date :
Jul 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Skin test with local extract

Skin prick test and intradermal test with local stinging insect allergen extracts that develop in Immunological division of Siriraj hospital, mahidol University

Diagnostic Test: Local insect allergen extracts skin test
Every patient received both local and commercial insect allergen extracts but in blinded methods
Other Names:
  • commercial insect allergen extracts from ALK skintest

    		•
    Sham Comparator: Skin test with commercial extract

    Skin prick test and intradermal test with commercial stinging insect allergen extracts that order from ALK company

    Diagnostic Test: Local insect allergen extracts skin test
    Every patient received both local and commercial insect allergen extracts but in blinded methods
    Other Names:
  • commercial insect allergen extracts from ALK skintest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of positive skin test results of local and commercial insect allergen extracts [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Siriraj hospital Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Nualanong Visitsunthorn, MD, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nualanong Visitsunthorn, Professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT03645291
    Other Study ID Numbers:
    • 450/2559 (EC 3)
    First Posted:
    Aug 24, 2018
    Last Update Posted:
    Aug 14, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nualanong Visitsunthorn, Professor, Mahidol University
    insect sting allergy
    Hymenoptera allergy
    local insect allergen extracts
    Additional relevant MeSH terms:
    Hypersensitivity
    Bites and Stings

    Study Results

    No Results Posted as of Aug 14, 2019