Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators
Rubber accelerators and control chamber/solution for NON-SLS group
+ Patch test on back
+ SLS
Dermatitis+6
+ Dermatitis, Contact
+ Hypersensitivity
Prevention Study
Summary
Study start date: February 5, 2024
Actual date on which the first participant was enrolled.This research aims to better understand how certain chemicals, found in rubber products like gloves, cause allergic skin reactions. Specifically, it looks at thiurams and carbamates, which are common ingredients that can lead to contact dermatitis, a skin irritation caused by direct contact with an allergen. The study will explore how different concentrations of these chemicals trigger reactions in people and whether damaged skin, like that from frequent hand washing, worsens the condition. This is important because it could lead to improved diagnosis and prevention strategies for those who work with rubber products and are prone to allergies. Participants in the study will be divided into two groups. One group will have their skin pre-irritated with a detergent called sodium lauryl sulfate (SLS) to mimic the effects of frequent hand washing, while the other group will not. After this, all participants will have their forearms exposed to the chemicals every night for a week, simulating the exposure from using rubber gloves. The skin reactions will be monitored and measured using a technique called laser Doppler flowmetry to assess blood flow changes in the skin. Additionally, participants will undergo patch tests on their upper backs to further investigate their skin's sensitivity to these chemicals. This approach helps determine the severity of reactions and improves understanding of how repeated exposure and pre-existing skin conditions affect allergic responses.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Department of Dermatology, Gentofte Hospital, Videncenter For Allergi
Hellerup, DenmarkOpen Department of Dermatology, Gentofte Hospital, Videncenter For Allergi in Google MapsDepartment of Dermatology and Allergy, Odense University Hospital (OUH)
Odense, Denmark