Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland

NCT06997393 | Active Not Recruiting

• 2 other identifiers: LF-ST-24-5000162024-15101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to investigate the effect of a prevention programme on hand eczema among workers in the Greenlandic fishing industry. This is a non-randomised clinical trial including employees at four of Royal Greenland's fish processing facilities in Greenland.

Conditions

Hand Eczema

Outcome Measures

Primary Outcomes (2)

• Change from baseline in knowledge of hand eczema at 3 months

  Knowledge of hand eczema measured by a self-reported questionnaire

  From enrollment to the end of intervention at 12 weeks

• Change from baseline in clinical severity of hand eczema at 3 months

  Clinical severity of hand eczema measured by Hand Eczema Severity Index (HECSI). The HECSI score ranges from 0 to 360, with higher scores reflecting greater disease severity.

  From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (5)

• Change from baseline in patient-reported quality of life at 3 months

  From enrollment to the end of intervention at 12 weeks

• Change from baseline in Patient Global Assessment of Disease Severity (PaGA) at 3 months

  From enrollment to the end of intervention at 12 weeks

• Change from baseline in the number of self-reported days with absence from work due to hand eczema at 3 months

  From enrollment to the end of intervention at 12 weeks

• Change from baseline in the number of participants being forced to change their job due to hand eczema at 3 months

  From enrollment to the end of intervention at 12 weeks

• Change from baseline in the availability of protective equipment at 3 months

  From enrollment to the end of intervention at 12 weeks

Study Arms (2)

Prevention programme

EXPERIMENTAL

The participants will have access to a prevention programme.

Behavioral: Prevention programme

Control group

NO INTERVENTION

The participants will not have access to a prevention programme.

Interventions

Prevention programme BEHAVIORAL

The prevention programme consists of a validated educational video and training in the basic recognition and prevention of hand eczema.

Prevention programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Employee in Royal Greenland, a state-owned company and one of the largest seafood enterprises in the world
• Written informed consent

You may not qualify if:

• Age below 18 years
• Inability to understand the Greenlandic, Danish or English language
• Pregnancy
• Other chronic skin diseases on the hands
• Receiving immunomodulatory therapies

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• LEO Foundation: collaborator
• University of Copenhagen: collaborator
• Greenland University: collaborator
• Government of Greenland, Agency for Health and Prevention: collaborator

Study Sites (4)

Royal Greenland

Ilulissat, Greenland

Location

Royal Greenland

Maniitsoq, Greenland

Location

Royal Greenland

Qasigiannguit, Greenland

Location

Royal Greenland

Sisimiut, Greenland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: June 10, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

GR (4)