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Contact Allergy to Rubber Accelerators - a Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06042309
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
National Allergy Research Center, Denmark

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Contact Allergy Other: Rubber accelerators and control chamber/solution for NON-SLS group Other: SLS Other: Rubber accelerators and control chamber/solution for SLS group Other: Patch test on back Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants are assigned to either the SLS-group or NON-SLS-group.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The forearm randomized to SLS and the order in which the different concentrations of thiurams and carbamates and the control solution are applied to the skin, will be blinded for the reader of the skin reactions and the latter also for the participant.
Primary Purpose: Prevention
Official Title: Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators
Actual Study Start Date : February 5, 2024
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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: 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
Experimental: SLS, Control participants
Participants not allergic to thiurams or carbamates assigned to the SLS group.
 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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042309


Contacts
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Contact: Christoffer Kursawe Larsen, MD +4538673940 christoffer.kursawe.larsen.01@regionh.dk

Locations
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Denmark
Department of Dermatology, Gentofte Hospital, Videncenter For Allergi Recruiting
Hellerup, Denmark, 2900
Contact: Christoffer K Larsen, MD    +4538673940    christoffer.kursawe.larsen.01@regionh.dk   
Sponsors and Collaborators
National Allergy Research Center, Denmark
More Information
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Responsible Party: National Allergy Research Center, Denmark
ClinicalTrials.gov Identifier: NCT06042309    
Other Study ID Numbers: H-22058515
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Allergic Contact
Hypersensitivity
Immune System Diseases
Dermatitis, Contact
Dermatitis
 Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Pharmaceutical Solutions