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Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04013763
Recruitment Status : Terminated (
  1. Limit number of patients during COVID-19 situation
  2. Too small number of wheat allergic patients who are using wheat containing soap
)
First Posted : July 10, 2019
Last Update Posted : September 7, 2020
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
Wheat allergy is increasing in Thailand. Some studies show that cutaneous exposure of allergen may cause allergy and there are many wheat containing skin care products that are over-the-counter. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to wheat and omega-5 gliadin in wheat allergy patients after stop using wheat containing skin care products.

Condition or disease Intervention/treatment Phase
Wheat Allergy Children Other: wheat containing skin care products Not Applicable

Detailed Description:
All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by medical history, medical examination included skin status (suspected atopic dermatitis or not). Blood sample was taken for baseline determination of immunoglobulin E antibodies to wheat and to omega-5 gliadin. Transepidermal water loss was examined in case with atopic dermatitis. The primary outcome was the specific immunoglobulin E antibodies to wheat and omega-5 gliadin in case that stop using wheat containing skin care product and case that continue using products.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Atopic dermatitis with stop using product
case wheat allergy with atopic dermatitis and stop using wheat containing skin care products
Other: wheat containing skin care products
stop or continue using wheat containing skin care products

Experimental: Atopic dermatitis with containing using product
case wheat allergy with atopic dermatitis and continue using wheat containing skin care products
Other: wheat containing skin care products
stop or continue using wheat containing skin care products

Experimental: Non atopic dermatitis with stop using product
case wheat allergy with normal skin and stop using wheat containing skin care products
Other: wheat containing skin care products
stop or continue using wheat containing skin care products

Experimental: Non atopic dermatitis with continue using product
case wheat allergy with normal skin and continue using wheat containing skin care products
Other: wheat containing skin care products
stop or continue using wheat containing skin care products

No Intervention: Atopic dermatitis with no product use
case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis
No Intervention: Non atopic dermatitis with no product use
case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis



Primary Outcome Measures :
  1. Specific IgE to wheat and omega-5 gliadin level [ Time Frame: 1 year ]
    To follow-up the level of wheat and omega5 gliadin specificIgE after stop using the wheat containing skin care product compare to patients who continue using the product.


Secondary Outcome Measures :
  1. level of transepidermal water loss [ Time Frame: 1 year ]
    To follow up the transepidermal water loss in patients with atopic dermatitis, comparing the group that continue using the product to the group that stop using the product.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children age 1 to 18 years
  • History of IgE-mediated wheat allergy

Exclusion Criteria:

  • Parents refused to sign the consent
  • severe atopic dermatitis
  • on oral immunothery
  • severe IgE mediated reaction after using wheat containing skin care product

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): NCT04013763


Locations
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Thailand
Siriraj hospital
Bangkok noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
National Research Council of Thailand
Investigators
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Principal Investigator: Punchama Pacharn, MD Mahidol University
Publications of Results:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04013763    
Other Study ID Numbers: 038/2562(EC1)
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
wheat allergy
skin sensitization
specific IgE
wheat containing skin care
Additional relevant MeSH terms:
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Hypersensitivity
Wheat Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate