Contact Allergy to Rubber Accelerators - a Clinical Study

• ClinicalTrials.gov Identifier: NCT06042309
• Recruitment Status: Recruiting
• First Posted: September 18, 2023
• Last Update Posted: March 22, 2024
• Sponsor: National Allergy Research Center, Denmark
• Information provided by (Responsible Party): National Allergy Research Center, Denmark

Tracking Information

• First Submitted Date: September 1, 2023
• First Posted Date: September 18, 2023
• Last Update Posted Date: March 22, 2024
• Actual Study Start Date: February 5, 2024
• Estimated Primary Completion Date: October 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2023)

• 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.
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Contact Allergy to Rubber Accelerators - a Clinical Study
• Official Title: Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Contact Allergy

Intervention

• 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: 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

Study Arms

• Experimental: NON-SLS, Allergic participants
  Participants allergic to thiurams or carbamates assigned to the NON-SLS group.
  Interventions:

  • Other: Rubber accelerators and control chamber/solution for NON-SLS group
  • Other: Patch test on back
• Experimental: NON-SLS, Control participants
  Participants not allergic to thiurams or carbamates assigned to the NON-SLS group.
  Interventions:

  • Other: Rubber accelerators and control chamber/solution for NON-SLS group
  • Other: Patch test on back
• Experimental: SLS, Allergic participants
  Participants allergic to thiurams or carbamates assigned to the SLS group.
  Interventions:

  • Other: SLS
  • Other: Rubber accelerators and control chamber/solution for SLS group
  • Other: Patch test on back
• Experimental: SLS, Control participants
  Participants not allergic to thiurams or carbamates assigned to the SLS group.
  Interventions:

  • Other: SLS
  • Other: Rubber accelerators and control chamber/solution for SLS group
  • Other: Patch test on back

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 11, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2025
• Estimated Primary Completion Date: October 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT06042309
• Other Study ID Numbers: H-22058515
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Allergy Research Center, Denmark
• Original Responsible Party: Same as current
• Current Study Sponsor: National Allergy Research Center, Denmark
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: National Allergy Research Center, Denmark
• Verification Date: September 2023