Occupational Contact DermatitisNCT04790799
Occupational Hand Eczema - Testing of a Prevention-concept
A study testing Treatment at the skin department at Gentofte Hospital in people with Occupational Contact Dermatitis, run by National Allergy Research Center, Denmark at 1 site in Denmark.
Trial summary
Randomised controlled trial examining the effect of decreased waiting time for the first doctors' appointment, patient education, glove counselling and counselling at departments of social or occupational medicine on severity of hand eczema, quality of life, use of corticosteroids, and jobsituation 3-12 months after… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Occupational Contact Dermatitis
- What is being tested?
- Treatment at the skin department at Gentofte Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jul 2020to 14 Jun 2023
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referred from a general practitioner to a dermatologist
- Hand eczema within the last 3 months
- Suspicion that the hand eczema is work-related (either patient and/or doctors suspicion)
Who cannot join
- Does not read and write danish
- Severe psychiatric illness
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational Hand Eczema - Establishment and Testing of a Prevention-concept With Focus on the Young Workforce
Randomised controlled trial examining the effect of decreased waiting time for the first doctors' appointment, patient education, glove counselling and counselling at departments of social or occupational medicine on severity of hand eczema, quality of life, use of corticosteroids, and jobsituation 3-12 months after intervention in patients with suspected occupational contact dermatitis of the hands.
Read the detailed description
Patients with suspected occupational hand eczema are recruited to the study on basis of their referral from general practitioner to dermatologist. Patients are randomised to either control or intervention group. The control group is treated and followed-up by the dermatologist they have been referred to, while the intervention group is treated and followed-up at Gentofte Hospital skin department with a maximum waiting time of 3 weeks. At the skin department at Gentofte Hospital, the patients in the intervention group receive patient education in prevention and treatment of hand eczema, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. Patients in both the control and intervention group are asked to fill out a questionnaire at 3, 6, 9 and 12 months after inclusion in the study. The questionnaire contains questions about quality of life, severity of hand exzema, jobsituation, use of healthcare service and use of medicine. Furthermore, prescriptions of medicine are registered in both control and intervention group at 3, 6, 9 and 12 months.
- Conditions
- Occupational Contact Dermatitis
- Being tested
- Treatment at the skin department at Gentofte Hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment at the skin department at Gentofte HospitalOther
Treatment in a hospital setting at Gentofte Hospital skin department
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Treatment in a hospital setting at Gentofte Hospital skin department with patient education, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. Receives: Other: Treatment at the skin department at Gentofte Hospital |
| Control group | No intervention | Treatment as usual (at a dermatologist office). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)
The hand eczema severity index (HECSI)
Measured: Change between baseline and 3 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
Measured: Change between baseline and 3 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
Measured: Change between baseline and 6 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
Measured: Change between baseline and 9 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
Measured: Change between baseline and 12 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Visual analog Score for severity of handeczema
Measured: Change between baseline and 3 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Visual analog Score for severity of handeczema
Measured: Change between baseline and 6 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Visual analog Score for severity of handeczema
Measured: Change between baseline and 9 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Visual analog Score for severity of handeczema
Measured: Change between baseline and 12 months
Amount of corticosteroids prescribed within the last year
Amount of corticosteroids prescribed wihtin the last year
Measured: Baseline
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Measured: 3 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Measured: 6 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Measured: 9 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Measured: 12 months
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Skindex-29
Measured: Baseline
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Skindex-29
Measured: 3 months
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Skindex-29
Measured: 6 months
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Skindex-29
Measured: 9 months
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Skindex-29
Measured: 12 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Measured: Baseline
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Measured: 3 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Measured: 6 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Measured: 9 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Measured: 12 months
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Dermatology life quality index (DLQI)
Measured: Baseline
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Dermatology life quality index (DLQI)
Measured: 3 months
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Dermatology life quality index (DLQI)
Measured: 6 months
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Dermatology life quality index (DLQI)
Measured: 9 months
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Dermatology life quality index (DLQI)
Measured: 12 months
Number of participants with loss of job within the last year
Self-repported loss of job wihtin the last year
Measured: Baseline
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Measured: Baseline
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Measured: 3 months
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Measured: 6 months
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Measured: 9 months
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Measured: 12 months
Amount of sick leave within the last year
Self-repported amount of sick leave within the last year
Measured: Baseline
Amount of sick leave within the last 3 months
Self-repported amount of sick leave within the last 3 months
Measured: 3 months
Amount of sick leave within the last 3 months
Self-repported amount of sick leave within the last 3 months
Measured: 6 months
Amount of sick leave within the last 3 months
Self-repported amount of sick leave within the last 3 months
Measured: 9 months
Amount of sick leave within the last 3 months
Self-repported amount of sick leave within the last 3 months
Measured: 12 months
Number of participants with change of occupation due to occupational contact dermatitis within the last year
Change of occupation due to occupational contact dermatitis within the last year
Measured: Baseline
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Change of occupation due to occupational contact dermatitis within the last 3 months
Measured: 3 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Change of occupation due to occupational contact dermatitis within the last 3 months
Measured: 6 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Change of occupation due to occupational contact dermatitis within the last 3 months
Measured: 9 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Change of occupation due to occupational contact dermatitis within the last 3 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start2 Jul 2020
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational Contact 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Allergy Research Center, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Arbejdsmiljøforskningsfonden, Bispebjerg Hospital, Frederiksberg University Hospital, National Research Centre for the Working Environment, Denmark, University of Osnabrueck
- Responsible party
- Principal investigator, Jojo Biel-Nielsen Dietz, National Allergy Research Center, Denmark
- Investigators
- Jeanne D Johansen, Professor, Study director, National Allergy Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790799
- Sponsor's protocol ID
- P-2019-650
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Hand Eczema - Establishment and Testing of a Prevention-concept With Focus on the Young Workforce
- ClinicalTrials.gov ID
- NCT04790799
- Acronym / sponsor ID
- P-2019-650
- Conditions
- Occupational Contact Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Allergy Research Center, DenmarkUniversity, hospital or other
- Collaborators
- Arbejdsmiljøforskningsfonden, Bispebjerg Hospital, Frederiksberg University Hospital, National Research Centre for the Working Environment, Denmark, University of Osnabrueck
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 10 Mar 2021 (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.
Randomised controlled trial examining the effect of decreased waiting time for the first doctors' appointment, patient education, glove counselling and counselling at departments of social or occupational medicine on severity of hand eczema, quality of life, use of corticosteroids, and jobsituation 3-12 months after intervention in patients with suspected occupational contact dermatitis of the hands.
Detailed description
Patients with suspected occupational hand eczema are recruited to the study on basis of their referral from general practitioner to dermatologist. Patients are randomised to either control or intervention group. The control group is treated and followed-up by the dermatologist they have been referred to, while the intervention group is treated and followed-up at Gentofte Hospital skin department with a maximum waiting time of 3 weeks. At the skin department at Gentofte Hospital, the patients in the intervention group receive patient education in prevention and treatment of hand eczema, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. Patients in both the control and intervention group are asked to fill out a questionnaire at 3, 6, 9 and 12 months after inclusion in the study. The questionnaire contains questions about quality of life, severity of hand exzema, jobsituation, use of healthcare service and use of medicine. Furthermore, prescriptions of medicine are registered in both control and intervention group at 3, 6, 9 and 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Treatment at the skin department at Gentofte HospitalTreatment in a hospital setting at Gentofte Hospital skin department with patient education, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. |
| Control group | No intervention | –Treatment as usual (at a dermatologist office). |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Referred from a general practitioner to a dermatologist
- Hand eczema within the last 3 months
- Suspicion that the hand eczema is work-related (either patient and/or doctors suspicion)
Key exclusion criteria (3 listed)
- Does not read and write danish
- Severe psychiatric illness
- Pregnancy
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 |
|---|---|---|
| Treatment at the skin department at Gentofte HospitalTreatment in a hospital setting at Gentofte Hospital skin department | Other | Intervention group |
Primary outcome
Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)
Time frame: Change between baseline and 3 months
The hand eczema severity index (HECSI)
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Time frame: Change between baseline and 3 months
Self-assessed photographic guide
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Time frame: Change between baseline and 6 months
Self-assessed photographic guide
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Time frame: Change between baseline and 9 months
Self-assessed photographic guide
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Time frame: Change between baseline and 12 months
Self-assessed photographic guide
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Time frame: Change between baseline and 3 months
Visual analog Score for severity of handeczema
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Time frame: Change between baseline and 6 months
Visual analog Score for severity of handeczema
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Time frame: Change between baseline and 9 months
Visual analog Score for severity of handeczema
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Time frame: Change between baseline and 12 months
Visual analog Score for severity of handeczema
Amount of corticosteroids prescribed within the last year
Time frame: Baseline
Amount of corticosteroids prescribed wihtin the last year
Amount of corticosteroids prescribed within the last 3 months
Time frame: 3 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Time frame: 6 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Time frame: 9 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Time frame: 12 months
Amount of corticosteroids prescribed within the last 3 months
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Time frame: Baseline
Skindex-29
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Time frame: 3 months
Skindex-29
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Time frame: 6 months
Skindex-29
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Time frame: 9 months
Skindex-29
Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)
Time frame: 12 months
Skindex-29
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Time frame: Baseline
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Time frame: 3 months
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Time frame: 6 months
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Time frame: 9 months
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Time frame: 12 months
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Time frame: Baseline
Dermatology life quality index (DLQI)
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Time frame: 3 months
Dermatology life quality index (DLQI)
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Time frame: 6 months
Dermatology life quality index (DLQI)
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Time frame: 9 months
Dermatology life quality index (DLQI)
Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)
Time frame: 12 months
Dermatology life quality index (DLQI)
Number of participants with loss of job within the last year
Time frame: Baseline
Self-repported loss of job wihtin the last year
Number of participants with loss of job within the last 3 months
Time frame: Baseline
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Time frame: 3 months
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Time frame: 6 months
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Time frame: 9 months
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Time frame: 12 months
Self-repported loss of job within the last 3 months
Amount of sick leave within the last year
Time frame: Baseline
Self-repported amount of sick leave within the last year
Amount of sick leave within the last 3 months
Time frame: 3 months
Self-repported amount of sick leave within the last 3 months
Amount of sick leave within the last 3 months
Time frame: 6 months
Self-repported amount of sick leave within the last 3 months
Amount of sick leave within the last 3 months
Time frame: 9 months
Self-repported amount of sick leave within the last 3 months
Amount of sick leave within the last 3 months
Time frame: 12 months
Self-repported amount of sick leave within the last 3 months
Number of participants with change of occupation due to occupational contact dermatitis within the last year
Time frame: Baseline
Change of occupation due to occupational contact dermatitis within the last year
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Time frame: 3 months
Change of occupation due to occupational contact dermatitis within the last 3 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Time frame: 6 months
Change of occupation due to occupational contact dermatitis within the last 3 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Time frame: 9 months
Change of occupation due to occupational contact dermatitis within the last 3 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Time frame: 12 months
Change of occupation due to occupational contact dermatitis within the last 3 months
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 9 Nov 2023.
- Individual participant dataSharing planned: No
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.
Jeanne D Johansen, Professor study director
National Allergy Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment at the skin department at Gentofte Hospital in people with Occupational Contact Dermatitis, run by National Allergy Research Center, Denmark at 1 site in Denmark.
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 3 inclusion and 3 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 9 Nov 2023. 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 Denmark. 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?
Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst) (time frame: Change between baseline and 3 months). The study lists 45 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 9 Nov 2023.