Back to resultsChildren With Aluminium Contact Allergy: Cutaneous Exposure Study
Primary Purpose
Contact Dermatitis, Contact Allergy, Aluminum Allergy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Repeated open application test
Sponsored by
About this trial
This is an interventional other trial for Contact Dermatitis focused on measuring vaccination granuloma, aluminium contact allergy, children, contact dermatitis, repeated open application test, patch test
Eligibility Criteria
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
Sites / Locations
- National Allergy Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
active test
placebo test
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04438135
First Posted
June 16, 2020
Last Updated
April 7, 2022
Sponsor
National Allergy Research Center, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04438135
Brief Title
Children With Aluminium Contact Allergy: Cutaneous Exposure Study
Official Title
Children With Aluminium Contact Allergy: Cutaneous Exposure Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
April 7, 2022 (Actual)
Study Completion Date
April 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Allergy Research Center, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis, Contact Allergy, Aluminum Allergy
Keywords
vaccination granuloma, aluminium contact allergy, children, contact dermatitis, repeated open application test, patch test
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Repeated Open Application test
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active test
Arm Type
Active Comparator
Arm Title
placebo test
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Repeated open application test
Intervention Description
parallel application of two different types of lotion with and without aluminium.
Primary Outcome Measure Information:
Title
positive test
Description
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.
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Duus Johansen, Prof.
Organizational Affiliation
National Allergy Research Centre
Official's Role
Study Director
Facility Information:
Facility Name
National Allergy Research Centre
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Children With Aluminium Contact Allergy: Cutaneous Exposure Study
We'll reach out to this number within 24 hrs