Contact Allergy to Rubber Accelerators - a Clinical Study

NCT06042309 | Completed

• 1 other identifier: H-22058515
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Contact Allergy

Outcome Measures

Primary Outcomes (2)

• Reading of skin reactions

  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

  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.

Study Arms (4)

NON-SLS, Allergic participants

EXPERIMENTAL

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

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

NON-SLS, Control participants

EXPERIMENTAL

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

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

SLS, Allergic participants

EXPERIMENTAL

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

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

SLS, Control participants

EXPERIMENTAL

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

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

Interventions

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.

NON-SLS, Allergic participants; NON-SLS, Control participants

SLS OTHER

Exposure to SLS on a randomized arm

SLS, Allergic participants; SLS, Control participants

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.

SLS, Allergic participants; SLS, Control participants

Patch test on back OTHER

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

NON-SLS, Allergic participants; NON-SLS, Control participants; SLS, Allergic participants; SLS, Control participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old
• Sensitized to thiurams, carbamates or both.
• Received written and oral information about the study.
• Signed written consent form

You may not qualify if:

• 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:
• adults ≥18 years old
• Received written and oral information about the study.
• Signed written consent form
• Sensitized to thiurams, carbamates or both.
• Occupational or domestical use of rubber gloves.
• History of atopic dermatitis or contact dermatitis

Sponsors & Collaborators

• National Allergy Research Center, Denmark: lead

Study Sites (2)

Department of Dermatology, Gentofte Hospital, Videncenter For Allergi

Hellerup, 2900, Denmark

Location

Department of Dermatology and Allergy, Odense University Hospital (OUH)

Odense, 5000, Denmark

Location

Related Publications (1)

• Kursawe Larsen C, Johansen JD, Zachariae C, Svedman C, Bergendorff O, Mortz CG, Schwensen JFB. Thresholds for Contact Allergy to a Rubber Accelerator: TETD-Determined by Serial Dilution Patch Testing and a Simulated Glove-Use Model. Contact Dermatitis. 2025 Aug;93(2):138-147. doi: 10.1111/cod.14817. Epub 2025 May 16.

  PMID: 40375756 DERIVED

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants are assigned to either the SLS-group or NON-SLS-group.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 18, 2023
• Study Start: February 5, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

DK (2)