Children With Aluminium Contact Allergy: Cutaneous Exposure Study (NCT04438135) | Clinical Trial Compass
CompletedNot Applicable
Children With Aluminium Contact Allergy: Cutaneous Exposure Study
Denmark15 participantsStarted 2020-06-10
Plain-language 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 of aluminium can cause skin reactions in children diagnosed with contact allergy to aluminium.
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 everyday use of a skin product.
Who can participate
Age range2 Years – 10 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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