Status:
COMPLETED
Children With Aluminium Contact Allergy: Cutaneous Exposure Study
Lead Sponsor:
National Allergy Research Center, Denmark
Conditions:
Contact Dermatitis
Contact Allergy
Eligibility:
All Genders
2-10 years
Phase:
NA
Brief Summary
Aluminium is used in many different cosmetic products, including make-up, deodorants and sunscreen. The purpose of this study is to investigate whether these everyday skin products with small amounts ...
Detailed Description
The study is conducted as a Repeated Open Application Test study (ROAT), a method originally developed to clarify the clinical relevance of questionable and positive patch samples, by imitating everyd...
Eligibility Criteria
Inclusion
- Children with contact allergies to aluminium, demonstrated by patch tests at the Skin and Allergy Department, Gentofte Hospital and thus registered in the Clinical Database for Contact Allergy.
- Activity (itching) of the granulom within the last six months
- Written consent obtained from all custodians.
- Self-assessed worsening of skin symptoms after contact with aluminium-containing sunscreens.
Exclusion
- Treatment with systemic steroid preparations within 1 week.
- Treatment with topical steroid preparations at or near the test area within 1 week.
- Treatment with systemic immune suppression.
- Treatment with antibiotics within 1 week.
- If the children become ill during the study, they should contact the project manager who will clinically assess the child and evaluate whether the child can continue to participate in the study or should be excluded due to the possibility of misinterpretation of any rash.
- Active eczema or other skin symptoms on the tested area
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04438135
Start Date
June 10 2020
End Date
April 7 2022
Last Update
April 8 2022
Active Locations (1)
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1
National Allergy Research Centre
Hellerup, Denmark, 2900