Contact Allergy to Rubber Accelerators - a Clinical Study

Sponsor

National Allergy Research Center, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06042309

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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

Primary Outcome Measures

Reading of skin reactions [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 [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

National Allergy Research Center, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Allergy Research Center, Denmark

ClinicalTrials.gov Identifier:

NCT06042309

Other Study ID Numbers:

H-22058515

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 18, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis, Allergic Contact

Hypersensitivity

Pharmaceutical Solutions

Study Results

No Results Posted as of Sep 18, 2023