Contact Allergy to Rubber Accelerators - a Clinical Study

March 20, 2024 updated by: National Allergy Research Center, Denmark

Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NON-SLS, Allergic participants
Participants allergic to thiurams or carbamates assigned to the NON-SLS group.
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: Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
Experimental: NON-SLS, Control participants
Participants not allergic to thiurams or carbamates assigned to the NON-SLS group.
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: Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
Experimental: SLS, Allergic participants
Participants allergic to thiurams or carbamates assigned to the SLS group.
Other: Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
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.
Experimental: SLS, Control participants
Participants not allergic to thiurams or carbamates assigned to the SLS group.
Other: Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading of skin reactions
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Allergy Research Center, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22058515

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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