Hand EczemaHEFIGNCT06997393
Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland
A study testing Prevention programme in people with Hand Eczema, run by Bispebjerg Hospital at 4 sites in Greenland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Eczema
- What is being tested?
- Prevention programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesGreenland
- Study dates
- 10 Jun 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employee in Royal Greenland, a state-owned company and one of the largest seafood enterprises in the world
- Written informed consent
Who cannot join
- Age below 18 years
- Inability to understand the Greenlandic, Danish or English language
- Pregnancy
- Other chronic skin diseases on the hands
- Receiving immunomodulatory therapies
Trial locations and contacts
4 sites in 1 country.
Greenland4 sites
Royal Greenland
Ilulissat
Royal Greenland
Maniitsoq
Royal Greenland
Qasigiannguit
Royal Greenland
Sisimiut
About this study
Official title: Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland: an Intervention Study
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
- Being tested
- Prevention programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention programmeBehavioural
The prevention programme consists of a validated educational video and training in the basic recognition and prevention of hand eczema.
| Study group | Role | What they receive |
|---|---|---|
| Prevention programme | Experimental | The participants will have access to a prevention programme. Receives: Behavioral: Prevention programme |
| Control group | No intervention | The participants will not have access to a prevention programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in knowledge of hand eczema at 3 months
Knowledge of hand eczema measured by a self-reported questionnaire
Measured: 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.
Measured: 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
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.
Measured: From enrollment to the end of intervention at 12 weeks
Change from baseline in Patient Global Assessment of Disease Severity (PaGA) at 3 months
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).
Measured: 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
The number of self-reported days with absence from work due to hand eczema measured by a questionnaire-based interview.
Measured: 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
The number of participants being forced to change their job due to hand eczema measured by a questionnaire-based interview.
Measured: From enrollment to the end of intervention at 12 weeks
Change from baseline in the availability of protective equipment at 3 months
The availability of protective equipment (protective gloves, cotton undergloves, moisturisers, and disinfectants) at the workplace measured by a questionnaire-based interview.
Measured: From enrollment to the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start10 Jun 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand EczemaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Foundation, University of Copenhagen, Greenland University, Government of Greenland, Agency for Health and Prevention
- Responsible party
- Principal investigator, Mathilde Tuborg Andersen, MD, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997393
- Sponsor's protocol ID
- LF-ST-24-500016
- Other IDs
- 2024-15101
- Acronym
- HEFIG
- Status last verified
- Aug 2025
- First submitted
- 14 May 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland: an Intervention Study
- ClinicalTrials.gov ID
- NCT06997393
- Acronym / sponsor ID
- HEFIG / LF-ST-24-500016
- Conditions
- Hand Eczema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- LEO Foundation, University of Copenhagen, Greenland University, Government of Greenland, Agency for Health and Prevention
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 May 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention programme | Experimental | Behavioral: Prevention programmeThe participants will have access to a prevention programme. |
| Control group | No intervention | –The participants will not have access to a prevention programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employee in Royal Greenland, a state-owned company and one of the largest seafood enterprises in the world
- Written informed consent
Key exclusion criteria (5 listed)
- Age below 18 years
- Inability to understand the Greenlandic, Danish or English language
- Pregnancy
- Other chronic skin diseases on the hands
- Receiving immunomodulatory therapies
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 |
|---|---|---|
| Prevention programmeThe prevention programme consists of a validated educational video and training in the basic recognition and prevention of hand eczema. | Behavioural | Prevention programme |
Primary outcome
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
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.
5 secondary outcomes
Change from baseline in patient-reported quality of life at 3 months
Time frame: From enrollment to the end of intervention at 12 weeks
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
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
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
Change from baseline in the availability of protective equipment at 3 months
Time frame: From enrollment to the end of intervention at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention programme in people with Hand Eczema, run by Bispebjerg Hospital at 4 sites in Greenland.
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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greenland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in knowledge of hand eczema at 3 months (time frame: From enrollment to the end of intervention at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.