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NCT06042309

Contact Allergy to Rubber Accelerators - a Clinical Study

Completed NA Last updated 17 January 2025
What this trial tests

NA trial testing Rubber accelerators and control chamber/solution for NON-SLS group in Contact Allergy in 18 participants. Completed in 20 December 2024.

Timeline
5 February 2024
Primary endpoint
20 December 2024
20 December 2024

Quick facts

Lead sponsorNational Allergy Research Center, Denmark
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment18
Start date5 February 2024
Primary completion20 December 2024
Estimated completion20 December 2024
Sites2 locations across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

National Allergy Research Center, Denmark

Who can join

18 and older, any sex, with Contact Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Thresholds for Contact Allergy to a Rubber Accelerator: TETD-Determined by Serial Dilution Patch Testing and a Simulated Glove-Use Model.
    Kursawe Larsen C, Johansen JD, Zachariae C, Svedman C, et al · · 2025 · cited 3× · PMID 40375756 · DOI 10.1111/cod.14817

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Trials by the same sponsor.

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