Contact Allergy to Rubber Accelerators - a Clinical Study

National Allergy Research Center, Denmark18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Contact Allergy

Rubber accelerators and control chamber/solution for NON-SLS groupOTHER

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.

SLSOTHER

Exposure to SLS on a randomized arm

Rubber accelerators and control chamber/solution for SLS groupOTHER

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 backOTHER

Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reading of skin reactions

Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.

Time frame: 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