NCT06042309

Contact Allergy to Rubber Accelerators - a Clinical Study

Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Allergy Research Center, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contact Allergy

Interventions

Type	Name	Description
OTHER	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.
OTHER	SLS	Exposure to SLS on a randomized arm
OTHER	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.
OTHER	Patch test on back	Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution

Timeline

• Start date: 2024-02-05
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2023-09-18
• Last updated: 2025-01-17

Locations

2 sites across 1 country: Denmark