Contact Allergy to Rubber Accelerators - a Clinical Study

National Allergy Research Center, Denmark

Status: Completed

Conditions: Contact Allergy

Treatments: Other: Patch test on back; Other: Rubber accelerators and control chamber/solution for SLS group; Other: SLS; Other: Rubber accelerators and control chamber/solution for NON-SLS group

Study type: Interventional

Funder types: Other

Identifiers

NCT06042309

H-22058515

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 4 patient groups

NON-SLS, Allergic participants

Experimental group

Description:

Participants allergic to thiurams or carbamates assigned to the NON-SLS group.

Treatment:

Other: Rubber accelerators and control chamber/solution for NON-SLS group

Other: Patch test on back

NON-SLS, Control participants

Experimental group

Description:

Participants not allergic to thiurams or carbamates assigned to the NON-SLS group.

Treatment:

Other: Rubber accelerators and control chamber/solution for NON-SLS group

Other: Patch test on back

SLS, Allergic participants

Experimental group

Description:

Participants allergic to thiurams or carbamates assigned to the SLS group.

Treatment:

Other: SLS

Other: Rubber accelerators and control chamber/solution for SLS group

Other: Patch test on back

SLS, Control participants

Experimental group

Description:

Participants not allergic to thiurams or carbamates assigned to the SLS group.

Treatment:

Other: SLS

Other: Rubber accelerators and control chamber/solution for SLS group

Other: Patch test on back