Children With Aluminium Contact Allergy: Oral Exposure Study

Status Completed

Clinical Trial Summary

Aluminium allergy is predominantly seen in children with small itchy nodules in the skin after vaccinations, so-called granulomas. We want to do an exposure study where aluminium allergic children have to eat aluminium pancakes for a short period of time. The purpose is to investigate whether a worsening of the children's symptoms can be detected, both itching of the granuloma, allergic rash on the skin and also the symptoms that are not measurable, such as headache, stomach ache and general agitation. We also want to examine the concentration of aluminium in the urine, which reflects the absorption of aluminum from the gastrointestinal tract.

Clinical Trial Description

Parents of aluminium allergic children have reported that children may react with increased itching of their granulomas, skin symptoms in the form of redness, itching and rash, as well as symptoms such as headache, abdominal pain and agitation, by ingesting aluminium-containing foods. Children are predominantly exposed to aluminium via the diet as they do not yet use aluminium-containing cosmetic products, stomach acid medicines or deodorants. The amount of aluminium in children's diet varies between 0.22-0.90 mg/kg body weight/week, depending on their age. In older children and adults, the intake is less related to the aluminium in infant formula, breakfast cereals and dried fruit, which is consumed more by children than adults. With this study, we want to create an exposure study where children have to eat pancakes for a limited period of time, where aluminium has been used as baking soda, and for two control periods eat pancakes without aluminium. Any symptoms occurring during periods could be used to investigate whether children with aluminium allergies generally react after intake of aluminium-containing foods and whether as such it is a consequential condition in some children or whether it is isolated cases. It is a very important issue to clarify with a view to proper advice, both with regard to the possible avoidance of specific foods and in the case of future vaccinations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04921163
Study type	Interventional
Source	National Allergy Research Center, Denmark
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2021
Completion date	June 15, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00371163` - Molecular and Cellular Characterization of Spongiotic Dermatitis	N/A
Completed	`NCT02028208` - Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study	Phase 2
Not yet recruiting	`NCT04853823` - A Safety, Tolerability, and Dermal Reactogenicity Study of PDC-APB	Phase 1
Completed	`NCT02700373` - A Phase I, Single-Center Study of PDC-APB in Healthy Volunteers	Phase 1
Completed	`NCT03089775` - Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis	Phase 1
Completed	`NCT04438135` - Children With Aluminium Contact Allergy: Cutaneous Exposure Study	N/A
Recruiting	`NCT06189144` - Testing an Intervention in Irritative Contact Dermatitis	N/A
Not yet recruiting	`NCT02026700` - Bariederm Cream in Chronic Contact Dermatitis	N/A
Completed	`NCT02028182` - Clinical Evaluation of Lyral® Dose Response Study	Phase 2
Completed	`NCT00824889` - Exploratory Study of Natural Killer Cells in Human Skin	N/A
Completed	`NCT00646867` - Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis	N/A
Withdrawn	`NCT01518348` - Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents	Phase 3
Recruiting	`NCT03705182` - Prevention of Dermatitis in Epoxy Exposed Workers	N/A
Terminated	`NCT03198390` - Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
Completed	`NCT00614289` - Novel Topical Treatment of Hand Dermatitis (Eczema)	Phase 1
Recruiting	`NCT06331390` - Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis	N/A
Completed	`NCT00640250` - Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response	Phase 2
Completed	`NCT00640614` - Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy	Phase 3
Recruiting	`NCT06177314` - Molecular Diagnosis of Allergic Contact Dermatitis
Completed	`NCT04772482` - Study on Hypoallergenic Hair Dye

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.