Contact Allergy to Rubber Accelerators - a Clinical Study

Contact Allergy Clinical Trial

Official title:

Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042309
• Other study ID #: H-22058515
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: September 2023
• Source: National Allergy Research Center, Denmark
• Contact: Christoffer Kursawe Larsen, MD
• Phone: +4538673940
• Email: christoffer.kursawe.larsen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contact Allergy
• Dermatitis, Allergic Contact
• Hypersensitivity

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.
• SLS
Exposure to SLS on a randomized arm
• 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.
• Patch test on back
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Gentofte Hospital, Videncenter For Allergi	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
National Allergy Research Center, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.