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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

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE May 30, 2018
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03645161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
Official Title  ICMJE Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Allergic Rhinitis Due to Animal Hair and Dander
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: rat and mouse skin test
  • 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.
    Intervention: Diagnostic Test: rat and mouse skin test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2018)
230
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2019
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03645161
Other Study ID Numbers  ICMJE 789/2560 (EC 2)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: publication
Responsible Party Nualanong Visitsunthorn, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nualanong Visitsunthorn, MD Department of Pediatrics, Siriraj hospital, Mahidol University
PRS Account Mahidol University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP