NCT03705182

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 3, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

October 2, 2018

Last Update Submit

September 1, 2020

Conditions

Contact DermatitisSensitization Dermatitis

Keywords

fluorescencedermal assessmentskin exposure

Outcome Measures

Primary Outcomes (2)

  • Change in sensitization

    Assesed by patch test

    At start and after 2 years

  • Change in prevalence of dermatitis

    Diagnosed by clinical examinations

    At start and after 2 years

Secondary Outcomes (2)

  • Change in fluorescence levels

    1 month x 4, over 2 years

  • Change in number of fluorescence recordings

    1 months x 4, over 2 years

Study Arms (2)

Interventiongroup

EXPERIMENTAL

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

Device: Fluorescence visualization (feedback)

Control group

NO INTERVENTION

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

Interventions

Fluorescence visualization (feedback)DEVICE

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

Interventiongroup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or more
  • Understand Danish or English

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Occupational medicine, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Henrik A. Kolstad, professor

    Department of Occupational Medicine, Aarhus University Hospital

    STUDY DIRECTOR

  • Alexandra G Christiansen, cand. med

    Department of Occupational Medicine, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra G. Christiansen, cand. med

CONTACT

+45 61369475Alexpe@rm.dk

Henrik A. Kolstad, professor

CONTACT

+45 78450900Henkol@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 15, 2018

Study Start

December 1, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2022

Last Updated

September 3, 2020

Record last verified: 2020-03

Locations

DK(1)