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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NON-SLS, Allergic participants | Experimental | Participants allergic to thiurams or carbamates assigned to the NON-SLS group. |
|
| NON-SLS, Control participants | Experimental | Participants not allergic to thiurams or carbamates assigned to the NON-SLS group. |
|
| SLS, Allergic participants | Experimental | Participants allergic to thiurams or carbamates assigned to the SLS group. |
|
| SLS, Control participants | Experimental | Participants not allergic to thiurams or carbamates assigned to the SLS group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rubber accelerators and control chamber/solution for NON-SLS group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reading of skin reactions | Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines. | 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. |
| Skin blood flow | Changes in blood flow on the arms using laser doppler flowmetry | 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. |
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Allergic participants
Inclusion Criteria:
Exclusion Criteria:
Healthy Controls:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Gentofte Hospital, Videncenter For Allergi | Hellerup | 2900 | Denmark | |||
| Department of Dermatology and Allergy, Odense University Hospital (OUH) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40375756 | Derived | 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. |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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The participants are assigned to either the SLS-group or NON-SLS-group.
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The forearm randomized to SLS and the order in which the different concentrations of thiurams and carbamates and the control solution are applied to the skin, will be blinded for the reader of the skin reactions and the latter also for the participant.
| SLS | Other | Exposure to SLS on a randomized arm |
|
| Rubber accelerators and control chamber/solution for SLS group | Other | 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 | Other | Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution |
|
| Odense |
| 5000 |
| Denmark |
| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |