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

Dermatitis Clinical Trial

— EPOXY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891743
• Other study ID #: LOD_VAG_011
• Status: Recruiting
• Start date: March 8, 2024
• Est. completion date: August 7, 2024

Study information

• Verified date: March 2024
• Source: Siemens Gamesa Renewable Energy Blades, S.A.
• Contact: Andreia Marques, PhD
• Phone: +351 936 766 893
• Email: ANDREIA.MARQUES.ext[@]siemensgamesa.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Epoxy resin systems are widely used materials in various industries due to their high mechanical, chemical, and thermal resistance. These systems are commonly employed as protective coatings, adhesives, and paints, as well as in the manufacturing of composites in the plastics industry. Epoxy components are well-known sensitizers of the skin. A high prevalence of skin sensitization and dermatitis have been reported among workers exposed to epoxy components. It is recommended to use comprehensive protective equipment when handling epoxy components. In the wind turbine industry, tasks involving epoxy handling, such as lamination and filling procedures, are frequently performed. Recent study have shown a sensitization prevalence of 8.9% among workers performing these tasks, while a previous study reported a high sensitization rate of 10.5% to epoxy resins. Despite efforts to find alternatives to epoxy resin systems and improve protective measures, the use of epoxy has increased, and some countries have implemented more stringent regulations, such as Denmark. In Portugal, there are currently no specific regulations regarding epoxy handling, and no certification is required for working with epoxy. Siemens Gamesa Renewable Energy, in Portugal, faces many skin problems among production workers, however numbers are unknown. Therefore, the main purpose of the study is to evaluate the prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind Turbine Industry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 7, 2024
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Workers from the wind turbine industry

Exclusion Criteria:

• Pregnant females

• Workers previously diagnosed with epoxy resin sensitization

Related Conditions & MeSH terms

• Dermatitis

Intervention

Diagnostic Test:
• Patch 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.

Locations

Country	Name	City	State
Portugal	Siemens Gamesa Renewable Energy (SGRE)	Aveiro	Soza

Sponsors (2)

Lead Sponsor	Collaborator
Siemens Gamesa Renewable Energy Blades, S.A.	Association for Innovation and Biomedical Research on Light and Image

Country where clinical trial is conducted

Portugal, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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