DermatitisEPOXYNCT05891743
Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry.
An observational study of Dermatitis, run by Siemens Gamesa Renewable Energy Blades, S.A. at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- Patch Test
- How many people
- 126 participants
- Where
- 1 sitePortugal
- Study dates
- 8 Mar 2024to 16 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Workers from the wind turbine industry
Who may be able to join
- Workers from the wind turbine industry
Who cannot join
- Pregnant females
- Workers previously diagnosed with epoxy resin sensitization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry
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?
Read more
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.
Read the detailed 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.
- Conditions
- Dermatitis
- Being tested
- Patch Test
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Epoxy_Group | Workers who are exposed to epoxy handling procedures, specifically filling and lamination tasks performed by production workers, mainly in finishing areas. Receives: 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. Receives: Diagnostic Test: Patch Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start8 Mar 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Gamesa Renewable Energy Blades, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Association for Innovation and Biomedical Research on Light and Image
- Responsible party
- Sponsor
- Investigators
- Vítor Pinheiro, MD, Principal investigator, AIBILI-CEC (AIBILI- Clinical Trials Centre)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891743
- Sponsor's protocol ID
- LOD_VAG_011
- Acronym
- EPOXY
- Status last verified
- Oct 2024
- First submitted
- 26 May 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26230376Prodi 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.
PubMed 25633931Geier 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.
PubMed 26537833Christiansen 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.
PubMed 35972390Ponten 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.
PubMed 15573646
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry
- ClinicalTrials.gov ID
- NCT05891743
- Acronym / sponsor ID
- EPOXY / LOD_VAG_011
- Conditions
- Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Siemens Gamesa Renewable Energy Blades, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Association for Innovation and Biomedical Research on Light and Image
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epoxy_Group | – | Diagnostic Test: Patch TestWorkers who are exposed to epoxy handling procedures, specifically filling and lamination tasks performed by production workers, mainly in finishing areas. |
| Non_exposed | – | Diagnostic Test: Patch TestWorkers from other areas unrelated to epoxy handling procedures, that will be included in the study as the non-exposed control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Workers from the wind turbine industry
Key inclusion criteria (1 listed)
- Workers from the wind turbine industry
Key exclusion criteria (2 listed)
- Pregnant females
- Workers previously diagnosed with epoxy resin sensitization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patch TestThe 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. | Diagnostic test | Epoxy_Group, Non_exposed |
Primary outcome
Prevalence of skin sensitization.
Time frame: 2-3 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 26230376Aalto-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.
- Background: PubMed 25633931Prodi 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.
- Background: PubMed 26537833Geier 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.
- Background: PubMed 35972390Christiansen 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.
- Background: PubMed 15573646Ponten 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vítor Pinheiro, MD principal investigator
AIBILI-CEC (AIBILI- Clinical Trials Centre)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, run by Siemens Gamesa Renewable Energy Blades, S.A. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of skin sensitization. (time frame: 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891743, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.