Children With Aluminium Contact Allergy: Cutaneous Exposure Study

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.

Study Overview

• Status: Completed
• Conditions: Contact Dermatitis; Contact Allergy; Aluminum Allergy
• Intervention / Treatment: Other: Repeated open application test

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 everyday use of a skin product.

The skin products will consist of ordinary sunscreens with and without aluminium, with colour code red and blue, respectively (masked for both investigator and participants). At the beginning of the trial, the study participants will be given the two creams. On the lower back of the children, two areas each 10 cm2 are marked with red and blue, respectively. In each area, sunscreen corresponding to the generally recommended amounts must be applied twice a day.

The children should be seen on day 0 for interviews and objective examination. They must then be seen again on day 7 and day 14. On day 14 of the ROAT, a patch test is made to validate the results of the ROAT study. The study is scheduled to last for a maximum of 21 days with 4-5 consultations per child. If there is a skin reaction in connection with the ROAT study before the 14 days have elapsed, the study will end and a patch test will be performed.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • National Allergy Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active test	Other: Repeated open application test; parallel application of two different types of lotion with and without aluminium.
Placebo Comparator: placebo test	Other: Repeated open application test; parallel application of two different types of lotion with and without aluminium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive test	After two weeks of daily application, both test sites on all children will be evaluated and scored according to ROAT guidelines. The ROAT will be considered positive at a score of 5 points or more. Photographs will be taken of all reactions (positive and negative) for documentation.	two weeks

Collaborators and Investigators

• Sponsor: National Allergy Research Center, Denmark
• Investigators: Study Director: Jeanne Duus Johansen, Prof., National Allergy Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: children; contact dermatitis; vaccination granuloma; aluminium contact allergy; repeated open application test; patch test
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: H-20009217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No