NCT04013763

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

July 1, 2019

Last Update Submit

April 7, 2022

Conditions

Wheat AllergyChildren

Keywords

wheat allergyskin sensitizationspecific IgEwheat containing skin care

Outcome Measures

Primary Outcomes (1)

  • Specific IgE to wheat and omega-5 gliadin level

    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.

    1 year

Secondary Outcomes (1)

  • level of transepidermal water loss

    1 year

Study Arms (6)

Atopic dermatitis with stop using product

EXPERIMENTAL

case wheat allergy with atopic dermatitis and stop using wheat containing skin care products

Other: wheat containing skin care products

Atopic dermatitis with containing using product

EXPERIMENTAL

case wheat allergy with atopic dermatitis and continue using wheat containing skin care products

Other: wheat containing skin care products

Non atopic dermatitis with stop using product

EXPERIMENTAL

case wheat allergy with normal skin and stop using wheat containing skin care products

Other: wheat containing skin care products

Non atopic dermatitis with continue using product

EXPERIMENTAL

case wheat allergy with normal skin and continue using wheat containing skin care products

Other: wheat containing skin care products

Atopic dermatitis with no product use

NO INTERVENTION

case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis

Non atopic dermatitis with no product use

NO INTERVENTION

case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis

Interventions

wheat containing skin care productsOTHER

stop or continue using wheat containing skin care products

Atopic dermatitis with containing using productAtopic dermatitis with stop using productNon atopic dermatitis with continue using productNon atopic dermatitis with stop using product

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Nakamura M, Yagami A, Hara K, Sano A, Kobayashi T, Aihara M, Hide M, Chinuki Y, Morita E, Teshima R, Matsunaga K. A new reliable method for detecting specific IgE antibodies in the patients with immediate type wheat allergy due to hydrolyzed wheat protein: correlation of its titer and clinical severity. Allergol Int. 2014 Jun;63(2):243-9. doi: 10.2332/allergolint.13-OA-0618. Epub 2014 Apr 25.

    PMID: 24759554RESULT

MeSH Terms

Conditions

Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Punchama Pacharn, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 10, 2019

Study Start

July 1, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

April 8, 2022

Record last verified: 2022-04

Locations

TH(1)