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NCT Number: NCT06042309

Contact Allergy to Rubber Accelerators - a Clinical Study

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.

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Key information

Conditions

Contact Allergy Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Gentofte Hospital, Videncenter For Allergi, Hellerup, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

SLS

Other

Exposure to SLS on a randomized arm

Rubber accelerators and control chamber/solution for SLS group

Other

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 back

Other

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

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

National Allergy Research Center, Denmark

Other

Registry information

Official study title

Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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