Contact Allergy to Rubber Accelerators - a Clinical Study
NCT ID: NCT06042309
Last Updated: 2025-01-17
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
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COMPLETED
NA
18 participants
INTERVENTIONAL
2024-02-05
2024-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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NON-SLS, Allergic participants
Participants allergic to thiurams or carbamates assigned to the NON-SLS group.
Rubber accelerators and control chamber/solution for NON-SLS group
Repeated exposure to rubber accelerators and control chamber/solution on arms. Three different concentrations of rubber accelerators and one control chamber/solution will be applied on the arms.
Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
NON-SLS, Control participants
Participants not allergic to thiurams or carbamates assigned to the NON-SLS group.
Rubber accelerators and control chamber/solution for NON-SLS group
Repeated exposure to rubber accelerators and control chamber/solution on arms. Three different concentrations of rubber accelerators and one control chamber/solution will be applied on the arms.
Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
SLS, Allergic participants
Participants allergic to thiurams or carbamates assigned to the SLS group.
SLS
Exposure to SLS on a randomized arm
Rubber accelerators and control chamber/solution for SLS group
Repeated exposure to rubber accelerators and control chamber/solution on arms. Two different concentrations of rubber accelerators and one control chamber/solution will be applied on both arms.
Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
SLS, Control participants
Participants not allergic to thiurams or carbamates assigned to the SLS group.
SLS
Exposure to SLS on a randomized arm
Rubber accelerators and control chamber/solution for SLS group
Repeated exposure to rubber accelerators and control chamber/solution on arms. Two different concentrations of rubber accelerators and one control chamber/solution will be applied on both arms.
Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
Interventions
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Rubber accelerators and control chamber/solution for NON-SLS group
Repeated exposure to rubber accelerators and control chamber/solution on arms. Three different concentrations of rubber accelerators and one control chamber/solution will be applied on the arms.
SLS
Exposure to SLS on a randomized arm
Rubber accelerators and control chamber/solution for SLS group
Repeated exposure to rubber accelerators and control chamber/solution on arms. Two different concentrations of rubber accelerators and one control chamber/solution will be applied on both arms.
Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
Eligibility Criteria
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Inclusion Criteria
* Sensitized to thiurams, carbamates or both.
* Received written and oral information about the study.
* Signed written consent form
* adults ≥18 years old
* Received written and oral information about the study.
* Signed written consent form
Exclusion Criteria
* 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:
* 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
18 Years
ALL
Yes
Sponsors
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National Allergy Research Center, Denmark
OTHER
Responsible Party
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Locations
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Department of Dermatology, Gentofte Hospital, Videncenter For Allergi
Hellerup, , Denmark
Department of Dermatology and Allergy, Odense University Hospital (OUH)
Odense, , Denmark
Countries
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References
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Kursawe Larsen C, Johansen JD, Zachariae C, Svedman C, Bergendorff O, Mortz CG, Schwensen JFB. Thresholds for Contact Allergy to a Rubber Accelerator: TETD-Determined by Serial Dilution Patch Testing and a Simulated Glove-Use Model. Contact Dermatitis. 2025 Aug;93(2):138-147. doi: 10.1111/cod.14817. Epub 2025 May 16.
Other Identifiers
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H-22058515
Identifier Type: -
Identifier Source: org_study_id
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