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Prevention of Dermatitis in Epoxy Exposed Workers

Primary Purpose

Contact Dermatitis, Sensitization Dermatitis

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fluorescence visualization (feedback)
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contact Dermatitis focused on measuring fluorescence, dermal assessment, skin exposure

Eligibility Criteria

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

Inclusion criteria:

  • 18 years of age or more
  • Understand Danish or English

Exclusion criteria:

  • Pregnant women
  • Severe dermatitis
  • Epilepsy
  • Current treatment with prednisolone

Sites / Locations

  • Department of Occupational medicine, Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventiongroup

Control group

Arm Description

The intervention group will be shown the fluorescent areas on their skin (fluorescence visualization feedback)

The control group will not be shown the fluorescent areas on their skin (no feedback)

Outcomes

Primary Outcome Measures

Change in sensitization
Assesed by patch test
Change in prevalence of dermatitis
Diagnosed by clinical examinations

Secondary Outcome Measures

Change in fluorescence levels
Levels of fluorescence, skin area exposed
Change in number of fluorescence recordings
Number of recordings during a day

Full Information

First Posted
October 2, 2018
Last Updated
September 1, 2020
Sponsor
Aarhus University Hospital
Collaborators
Arbejdsmiljøforskningsfonden, Vestas Wind Power, Siemens Gamesa Renewable Energy, Skane University Hospital, Herning Hospital, National Research Centre for the Working Environment, Denmark, Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03705182
Brief Title
Prevention of Dermatitis in Epoxy Exposed Workers
Official Title
Prevention of Dermatitis in Epoxy Exposed Lamination Workers Producing Wind Turbine Blades: An Intervention Study Using Fluorescence Visualization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital
Collaborators
Arbejdsmiljøforskningsfonden, Vestas Wind Power, Siemens Gamesa Renewable Energy, Skane University Hospital, Herning Hospital, National Research Centre for the Working Environment, Denmark, Aalborg University Hospital

4. Oversight

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

5. Study Description

Brief Summary
The risk of sensitization and contact dermatitis among workers exposed to epoxy resin systems (ERS) is high despite extensive preventive efforts, probably because skin exposure is often left unrecognized. The main objective of this project is to prevent epoxy-related dermatitis and sensitization, caused by working with ERS, by fluorescence visualization of exposure. In cooperation with global manufacturers of wind turbines, 250 lamination workers will be allocated to either an intervention or a control Group. The risk of dermatitis and sensitization will be compared. Skin exposure will be made visible by a fluorescent tracer added to the ERS. UVA-light will illuminate the skin of head, neck, arms and hands and the fluorescent areas will be recorded and quantified by a computer vision system. The intervention group will be shown the fluorescent areas on their skin, while the control group will not have this information. The intervention takes place daily for a period of 1 month, 4 times during the 2 year follow up period. All participants are patch tested, screened for dermatitis and atopy at start and end of follow up or at end of employment. The investigators also assess potential determinants for ERS exposure including working tasks and procedures. Information on dermatitis diagnoses from hospital contacts, medical prescriptions and education will be obtained from registers.
Detailed Description
Objectives The overarching objective is to reduce the risk of dermatitis and sensitization when working with epoxy resin systems. Specific aims are: To identify work procedures at increased risk of dermal exposure to epoxy resins To examine if fluorescence visualization of dermal exposure to epoxy resins reduces the risk of: subsequent dermal exposure to epoxy resins dermatitis sensitization to epoxy resins To examine the risk of dermatitis following sensitization to ERS components To examine the course of sensitization to ERS components. Materials and methods Study population The study population is 250 employees of two factories producing rotor blades for wind turbines. The participants all have daily manual work with ERS. Participants will be recruited through the Health Safety and Environment (HSE) organizations by oral and written information. Current employees will be followed for 2 years. Employees employed during the study will continuously be recruited and followed until end of follow up, 2 years after study start. Measurement of exposure ERS used in the production of wind turbines is fluorescent under UVA-light. We have developed a computer vision system which will illuminate the skin of the workers and record the fluorescent areas on the exposed skin areas. The system will, for milliseconds, illuminate the skin of head, neck, arms and hands with UVA-light that does not allow the participants to notice the fluorescent skin areas. Digital images of the fluorescent areas will be displayed to the participants on a screen. Participants will record skin exposure with the vision system every time a production area is left i.e. for lunch breaks, toilet visits and at the end of a work day. At each time, participants will report work procedures and use of protective equipment during the preceding few hours and this information will be stored and linked with the skin exposure measurements. The participants will be able to operate the system themselves; it will register and store all data inclusive their identity for later analysis. The system is handy and can be transported easily and the procedure will only take a couple minutes. The fluorescence measurements will take place daily for a period of 1-2 month, 4 times during the 2 year follow up period. Questionnaire At start and end of follow up, participants are asked to fill in a brief questionnaire concerning recent and former skin rashes, allergies, atopic dermatitis, asthma and life style factors. The questionnaire will be a shortened version of the Nordic Occupational Skin Questionnaire and ECRHS. Clinical examination and blood samples To test for atopy, participants will provide a blood sample for subsequent analysis of specific IgE for standard inhalation allergens. Participants reporting skin rash or symptoms from airways will be invited to a clinical examination for diagnostic classification.Photo documentation of the skin will be performed. Patch testing All participants will be patch tested for ERS components. a specially profiled occupational patch test series will be developed as done in former studies of epoxy exposed workers. The test materials are diluted according to recommended test concentrations. New materials are tested on 20 patients with dermatitis from the Yrkes och Miljödermatologisk Afdeling, Skånes Universitetssjukhus. Test concentrations are subsequently adjusted if necessary. A dilution series on the 20 test patients will be added in order to evaluate the degree of sensitization by positive reactions. All participants are also tested with the European standard patch test series. Patch testing will be performed at the workplaces at start and end of follow up. Employees terminating employment during the study period will be contacted at home for testing. The test material will be placed on the back, occluded for 48 hours with readings at day 3, 4 and 7. The backs of the participants will be photographed prior to application and in connection with the readings. Possible skin reactions later than day 7 will be obtained by a questionnaire supplemented with photo documentation by the participants. Register data Information about prescribed medications, hospital contacts (diagnoses), education and other possible confounders or modifying factors will be obtained through linkage with national registers. Data will be uploaded and anonymized at Statistics Denmark. Intervention The 250 participants will be allocated to an intervention- or a control group, around 125 in each. The intervention group will be shown the fluorescent areas on their skin, while the control group will not have this opportunity. Work teams of 40 workers will be allocated together. A group of 600 office workers will be asked to fill in the questionnaire. Of the 600 workers 100 will be asked to be patch tested and to provide a blood sample. Compliance The investigators will on a weekly basis monitor study compliance by checking the frequency of the use of the visualization system. The quality of the visualization data obtained, will also be monitored. The statistical results will continuously be evaluated together with the HSE-responsible of the factories. Statistical analyses The investigators will analyze how different work procedures and protective equipment predict intensity of skin exposure to epoxy resins in the control group. The analytical unit will be exposure registrations and level of fluorescence. Since each participant will contribute multiple recordings, data will be analyzed with mixed logistic and linear regression. The effect of visualization on the risk of subsequent exposure will be analyzed by comparing the occurrence of skin exposure in the intervention group with the control group. Data will be analyzed with mixed logistic regression for reasons as above. The effect of visualization on the risk of dermatitis and sensitization to epoxy resin systems will also be accomplished by comparing the intervention with the control group. The analytical unit will be the individual participant and data are thus analyzed with traditional logistic regression. Participants with dermatitis or sensitization to epoxy resin systems at baseline will be excluded from these analyses. All analyses will be adjusted for relevant confounders based on Direct Acyclic Graph (DAGs). Statistical power Based on the expected incidence of dermatitis in a wind turbine plant, around 225 participants in the intervention group and the control group, respectively, a follow up of 2 years, and an expected annual incidence of dermatitis of 5 % in the control group, the investigators will be able to detect reductions of 75% and 50% in the intervention group with a power of 97% and 56%, respectively. Perspectives If exposure visualization reduces the risk of dermatitis and sensitization to epoxy resin systems, this may have significant impact on the health of the many who work with these materials worldwide. Global manufacturers of wind turbines and composite materials are involved in the project and this is expected to facilitate the dissemination globally. Follow up studies of persistent exposure to potent skin sensitizers with repeated patch testing has rarely been done and the study may furthermore provide new insight to the epidemiology of allergic dermatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis, Sensitization Dermatitis
Keywords
fluorescence, dermal assessment, skin exposure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The 250 participants will be allocated to an intervention- or a control group, around 125 in each. The intervention group will be shown the fluorescent areas on their skin, while the control group will not have this opportunity. Work teams of approximately 40 workers with comparable work procedures, are allocated together.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventiongroup
Arm Type
Experimental
Arm Description
The intervention group will be shown the fluorescent areas on their skin (fluorescence visualization feedback)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not be shown the fluorescent areas on their skin (no feedback)
Intervention Type
Device
Intervention Name(s)
Fluorescence visualization (feedback)
Intervention Description
UVA-light will illuminate the skin of head, neck, arms and hands and the fluorescent areas will be recorded and quantified by a computer vision system each time the participant leaves a production area. The intervention group will be shown the fluorescent areas on their skin, the control group will not have this opportunity
Primary Outcome Measure Information:
Title
Change in sensitization
Description
Assesed by patch test
Time Frame
At start and after 2 years
Title
Change in prevalence of dermatitis
Description
Diagnosed by clinical examinations
Time Frame
At start and after 2 years
Secondary Outcome Measure Information:
Title
Change in fluorescence levels
Description
Levels of fluorescence, skin area exposed
Time Frame
1 month x 4, over 2 years
Title
Change in number of fluorescence recordings
Description
Number of recordings during a day
Time Frame
1 months x 4, over 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 18 years of age or more Understand Danish or English Exclusion criteria: Pregnant women Severe dermatitis Epilepsy Current treatment with prednisolone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra G. Christiansen, cand. med
Phone
+45 61369475
Email
Alexpe@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik A. Kolstad, professor
Phone
+45 78450900
Email
Henkol@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik A. Kolstad, professor
Organizational Affiliation
Department of Occupational Medicine, Aarhus University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexandra G Christiansen, cand. med
Organizational Affiliation
Department of Occupational Medicine, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Occupational medicine, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra G Christisansen, MD
Phone
+45 61369475
Email
Alexpe@rm.dk
First Name & Middle Initial & Last Name & Degree
Henrik A. Kolstad, professor
Phone
+45 78450900
Email
Henkol@rm.dk

12. IPD Sharing Statement

Learn more about this trial

Prevention of Dermatitis in Epoxy Exposed Workers

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