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Contact Allergy to Rubber Accelerators - a Clinical Study

Primary Purpose

Contact Allergy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rubber accelerators and control chamber/solution for NON-SLS group
SLS
Rubber accelerators and control chamber/solution for SLS group
Patch test on back
Sponsored by
National Allergy Research Center, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contact Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    NON-SLS, Allergic participants

    NON-SLS, Control participants

    SLS, Allergic participants

    SLS, Control participants

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Reading of skin reactions
    Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.
    Skin blood flow
    Changes in blood flow on the arms using laser doppler flowmetry

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2023
    Last Updated
    September 11, 2023
    Sponsor
    National Allergy Research Center, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06042309
    Brief Title
    Contact Allergy to Rubber Accelerators - a Clinical Study
    Official Title
    Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Allergy Research Center, Denmark

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Contact Allergy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants are assigned to either the SLS-group or NON-SLS-group.
    Masking
    ParticipantOutcomes 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.
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NON-SLS, Allergic participants
    Arm Type
    Experimental
    Arm Description
    Participants allergic to thiurams or carbamates assigned to the NON-SLS group.
    Arm Title
    NON-SLS, Control participants
    Arm Type
    Experimental
    Arm Description
    Participants not allergic to thiurams or carbamates assigned to the NON-SLS group.
    Arm Title
    SLS, Allergic participants
    Arm Type
    Experimental
    Arm Description
    Participants allergic to thiurams or carbamates assigned to the SLS group.
    Arm Title
    SLS, Control participants
    Arm Type
    Experimental
    Arm Description
    Participants not allergic to thiurams or carbamates assigned to the SLS group.
    Intervention Type
    Other
    Intervention Name(s)
    Rubber accelerators and control chamber/solution for NON-SLS group
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    SLS
    Intervention Description
    Exposure to SLS on a randomized arm
    Intervention Type
    Other
    Intervention Name(s)
    Rubber accelerators and control chamber/solution for SLS group
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Patch test on back
    Intervention Description
    Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
    Primary Outcome Measure Information:
    Title
    Reading of skin reactions
    Description
    Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.
    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.
    Title
    Skin blood flow
    Description
    Changes in blood flow on the arms using laser doppler flowmetry
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christoffer Kursawe Larsen, MD
    Phone
    +4538673940
    Email
    christoffer.kursawe.larsen.01@regionh.dk

    12. IPD Sharing Statement

    Learn more about this trial

    Contact Allergy to Rubber Accelerators - a Clinical Study

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