Children With Aluminium Contact Allergy: Cutaneous Exposure Study

NCT04438135 | Completed

• 1 other identifier: H-20009217
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Contact Dermatitis; Contact Allergy; Aluminum Allergy

Keywords

vaccination granuloma; aluminium contact allergy; children; contact dermatitis; repeated open application test; patch test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

active test

ACTIVE COMPARATOR

Other: Repeated open application test

placebo test

PLACEBO COMPARATOR

Other: Repeated open application test

Interventions

Repeated open application test OTHER

parallel application of two different types of lotion with and without aluminium.

active test; placebo test

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Allergy Research Center, Denmark: lead

Study Sites (1)

National Allergy Research Centre

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Contact; Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Jeanne Duus Johansen, Prof.

  National Allergy Research Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated Open Application test

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: June 10, 2020
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: April 8, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)