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NCT Number: NCT06997393

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hand Eczema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Greenland, Ilulissat, Greenland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Prevention programme

Behavioral

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

Primary outcomes

  1. Change from baseline in knowledge of hand eczema at 3 months

    Time frame: From enrollment to the end of intervention at 12 weeks

    Knowledge of hand eczema measured by a self-reported questionnaire

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

    Time frame: From enrollment to the end of intervention at 12 weeks

    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.

Secondary outcomes

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

    Time frame: From enrollment to the end of intervention at 12 weeks

    Patient-reported quality of life measured by Hand Eczema Impact Scale (HEIS). The HEIS is a validated 9-item questionnaire that measure the impact of hand eczema on patients' quality of life, based on recall over the past week. Domains include proximal daily activity limitations, embarrassment with the appearance of the hands, frustration with chronic hand eczema, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items.

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

    Time frame: From enrollment to the end of intervention at 12 weeks

    The PaGA rates the severity of the patient's global disease assessed by the patient and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

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

    Time frame: From enrollment to the end of intervention at 12 weeks

    The number of self-reported days with absence from work due to hand eczema measured by a questionnaire-based interview.

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

    Time frame: From enrollment to the end of intervention at 12 weeks

    The number of participants being forced to change their job due to hand eczema measured by a questionnaire-based interview.

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

    Time frame: From enrollment to the end of intervention at 12 weeks

    The availability of protective equipment (protective gloves, cotton undergloves, moisturisers, and disinfectants) at the workplace measured by a questionnaire-based interview.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Government of Greenland, Agency for Health and Prevention
  • Greenland University
  • LEO Foundation
  • University of Copenhagen

Registry information

Official study title

Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland: an Intervention Study

Acronym: HEFIG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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