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

Not Applicable

Terminated

• Conditions: Children; Wheat Allergy
• Interventions: Other: wheat containing skin care products

• Registration Number: NCT04013763
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atopic dermatitis with stop using product	wheat containing skin care products	case wheat allergy with atopic dermatitis and stop using wheat containing skin care products
Atopic dermatitis with containing using product	wheat containing skin care products	case wheat allergy with atopic dermatitis and continue using wheat containing skin care products
Non atopic dermatitis with stop using product	wheat containing skin care products	case wheat allergy with normal skin and stop using wheat containing skin care products
Non atopic dermatitis with continue using product	wheat containing skin care products	case wheat allergy with normal skin and continue using wheat containing skin care products

Primary Outcome Measures

Name	Time	Method
Specific IgE to wheat and omega-5 gliadin level	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

Name	Time	Method
level of transepidermal water loss	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.

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok noi, Bangkok, Thailand