Contact Allergy to Rubber Accelerators - a Clinical Study (NCT06042309) | Clinical Trial Compass
CompletedNot Applicable
Contact Allergy to Rubber Accelerators - a Clinical Study
Denmark18 participantsStarted 2024-02-05
Plain-language summary
This study will investigate what concentrations of the most common thiurams and carbamates that elicit allergic contact dermatitis under patch test and what concentrations of the rubber accelerators that elicit allergic contact dermatitis by repeated exposures under simulated use conditions. Further, it will investigate whether a damaged skin barrier as caused by wet work increase the severity of the allergic contact dermatitis.
The participants will be assigned to either the SLS (sodium lauryl sulfate)-group or non SLS-group. For the participants of the SLS-group, one volar forearm will be randomized to be pre-irritated with a soap i.e. detergent: sodium lauryl sulfate (SLS) for 24 hours to simulate wet work. The participants of the non SLS-group will not be pre-irritated with SLS.
Following this, the participants' volar forearms will be exposed to thiurams or carbamates and a control solution every night for 7 nights to simulate the repeated exposure to rubber gloves with accelerators. The skin reactions will be read cf. current international guidelines and further quantified using laser Doppler flowmetry.
During the study, all participants will be patch tested on the upper back with rubber accelerators to investigate their current degree of sensitization and the dose-response relationships.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Allergic participants
Inclusion Criteria:
* Adults ≥18 years old
* Sensitized to thiurams, carbamates or both.
* Received written and oral information about the study.
* Signed written consent form
Exclusion Criteria:
* Dermatitis on back or arms
* Tattoos or significant scar tissue on exposure areas
* Pregnancy
* Breast feeding
* Recently given birth
* Treatment with systemic immunomodulators within the last 4 weeks
* Treatment with local immunomodulators on arms or back within the last 4 weeks
* Excessive ultraviolet light on arms or back within the last 4 weeks
Healthy Controls:
Inclusion Criteria:
* adults ≥18 years old
* Received written and oral information about the study.
* Signed written consent form
Exclusion Criteria:
* Sensitized to thiurams, carbamates or both.
* Occupational or domestical use of rubber gloves.
* History of atopic dermatitis or contact dermatitis
* Dermatitis on back or arms
* Tattoos or significant scar tissue on exposure areas
* Pregnancy
* Breast feeding
* Recently given birth
* Treatment with systemic immunomodulators within the last 4 weeks
* Treatment with local immunomodulators on arms or back within the last 4 weeks
* Excessive ultraviolet light on arms or back within the last 4 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reading of skin reactions
Timeframe: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
2
Skin blood flow
Timeframe: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.