Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry.

NCT05891743 | Completed

• 1 other identifier: LOD_VAG_011
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study it to learn about the prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind turbine industry. The main question it aims to answer is: \- What is the prevalence of skin sensitization and dermatitis among workers in the wind turbine industry who are exposed to epoxy? Participants will be asked to perform Patch Test, which is considered the Gold Standard test for identifying the cause of occupational contact allergic dermatitis. Researchers will compare the results of the epoxy-exposed group with those of a control group comprising non-exposed workers from the same industry. This analysis will help determine if there is a higher prevalence of skin sensitization among workers exposed to epoxy.

Conditions

Dermatitis

Outcome Measures

Primary Outcomes (1)

• Prevalence of skin sensitization.

  Allergens will be applied to the participant's back using IQ Chambers® (Chemotechnique) and secured with 4fix® adhesive tape for 48 hours. Readings will be conducted on day 2-3 and, if necessary, on days 4-7, following the ESCD guidelines.

  2-3 days

Study Arms (2)

Epoxy_Group

Workers who are exposed to epoxy handling procedures, specifically filling and lamination tasks performed by production workers, mainly in finishing areas.

Diagnostic Test: Patch Test

Non_exposed

Workers from other areas unrelated to epoxy handling procedures, that will be included in the study as the non-exposed control group.

Diagnostic Test: Patch Test

Interventions

Patch Test DIAGNOSTIC_TEST

The Patch Test will include the European baseline series, as well as the epoxy and isocyanate series. Additionally, specific products commonly used in the workplace, such as glues, resins, and paints, will be prepared and included in the testing.

Epoxy_Group; Non_exposed

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Workers from the wind turbine industry

You may qualify if:

• Workers from the wind turbine industry

You may not qualify if:

• Pregnant females
• Workers previously diagnosed with epoxy resin sensitization

Sponsors & Collaborators

• Siemens Gamesa Renewable Energy Blades, S.A.: lead
• Association for Innovation and Biomedical Research on Light and Image: collaborator

Study Sites (1)

Siemens Gamesa Renewable Energy (SGRE)

Aveiro, Soza, 3840-346, Portugal

Location

Related Publications (5)

• Aalto-Korte K, Pesonen M, Suuronen K. Occupational allergic contact dermatitis caused by epoxy chemicals: occupations, sensitizing products, and diagnosis. Contact Dermatitis. 2015 Dec;73(6):336-42. doi: 10.1111/cod.12445. Epub 2015 Jul 30.

  PMID: 26230376 BACKGROUND

• Prodi A, Rui F, Fortina AB, Corradin MT, Filon FL. Occupational sensitization to epoxy resins in Northeastern Italy (1996-2010). Int J Occup Environ Health. 2015;21(1):82-7. doi: 10.1179/2049396714Y.0000000095.

  PMID: 25633931 BACKGROUND

• Geier J, Lessmann H, Hillen U, Skudlik C, Jappe U. Sensitization to reactive diluents and hardeners in epoxy resin systems. IVDK data 2002-2011. Part II: concomitant reactions. Contact Dermatitis. 2016 Feb;74(2):94-101. doi: 10.1111/cod.12490. Epub 2015 Nov 5.

  PMID: 26537833 BACKGROUND

• Christiansen AG, Carstensen O, Sommerlund M, Clausen PA, Bonlokke JH, Schlunssen V, Isaksson M, Schmidt SAJ, Kolstad HA. Prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind turbine industry. Br J Dermatol. 2022 Dec;187(6):988-996. doi: 10.1111/bjd.21830. Epub 2022 Sep 16.

  PMID: 35972390 BACKGROUND

• Ponten A, Carstensen O, Rasmussen K, Gruvberger B, Isaksson M, Bruze M. Epoxy-based production of wind turbine rotor blades: occupational contact allergies. Dermatitis. 2004 Mar;15(1):33-40. doi: 10.2310/6620.2004.20433.

  PMID: 15573646 BACKGROUND

MeSH Terms

Conditions

Dermatitis

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Vítor Pinheiro, MD

  AIBILI-CEC (AIBILI- Clinical Trials Centre)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 7, 2023
• Study Start: March 8, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

PT (1)