Children With Aluminium Contact Allergy: Cutaneous Exposure Study
NCT ID: NCT04438135
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
15 participants
INTERVENTIONAL
2020-06-10
2022-04-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Contact Allergy to Rubber Accelerators - a Clinical Study
NCT06042309
Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study
NCT03313232
Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool
NCT05858723
Quaternium-15, Use Test
NCT00311454
Allergy to Almond in Children
NCT04407104
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
active test
Repeated open application test
parallel application of two different types of lotion with and without aluminium.
placebo test
Repeated open application test
parallel application of two different types of lotion with and without aluminium.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Repeated open application test
parallel application of two different types of lotion with and without aluminium.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
2 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Allergy Research Center, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeanne Duus Johansen, Prof.
Role: STUDY_DIRECTOR
National Allergy Research Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Allergy Research Centre
Hellerup, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-20009217
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.