EczemaHETNCT01012453
A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema
A study testing A randomised clinical trial of the effect of classification and individual counselling in people with Eczema and Dermatitis, run by Zealand University Hospital at 3 sites in Denmark.
Trial summary
Objectives and perspective: 1. To estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . To investigate the knowledge of skin protection among health care workers. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eczema, Dermatitis, Skin Disease
- What is being tested?
- A randomised clinical trial of the effect of classification and individual counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesDenmark
- Study dates
- Oct 2009to Oct 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
- Informed written consent must be present in order to participate.
Who cannot join
- Pregnancy
- Systemic use of immunosuppressive drugs
- Systemic use of retinoids
- Active psoriatic lesions on the hands
- Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
- Lack of informed written consent
Trial locations and contacts
3 sites in 1 country.
Tove Agner, MD, DM Science contact
Denmark3 sites, 3 recruiting
- Not yet recruiting
Holbaek Hospital
Holbæk, 4300
Kristina Sophie Ibler, MD, Ph.d-student
- Not yet recruiting
Koege Hospital
Koege, 4600
kristina Sophie Ibler, MD, Ph.d-student
- Recruiting
Dermatological Department, Roskilde County Hospital
Roskilde, 4000
Kristina Sophie Ibler, Md, Ph.d-student
About this study
Official title: Hand Eczema Trial: A Randomised Clinical Trial of the Effect of Classification and Individual Counselling Among Health Care Workers With Hand Eczema
Objectives and perspective:
- To estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . To investigate the knowledge of skin protection among health care workers.
- To classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema
- To evaluate the effect of a combination of classification of hand eczema and individual work-related counseling in skin protective behavior.
Read more
The overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers.
Hypotheses:
- Irritant contact dermatitis is more common than allergic contact dermatitis.
- The combination of precise classification (subtyping of HE) and individual counseling will have a positive impact on the prognosis of hand eczema.
- The positive impact on the prognosis of hand eczema will have a positive impact on quality of life (QoL).
- The knowledge of protective behavior will increase.
- Education in a skin care program will have a positive impact on skin protective behavior.
- Conditions
- Eczema, Dermatitis, Skin Disease
- Being tested
- A randomised clinical trial of the effect of classification and individual counselling
- Keywords
- Hand eczema, Hand dermatitis, Occupational skin disease, skindisease in health care workers, occupational hand dermatitis, occupational hand eczema
- Medical subject headings
- Eczema, Dermatitis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A randomised clinical trial of the effect of classification and individual counsellingBehavioural
The trial to be conducted is a randomised single-blinded parallel study. It is divided in two stages, T = 0 and follow-up at T = 6 months. All included participants will have a clinical examination at the beginning and at follow-up in the trial. Half of the participants will be randomised to intervention, the other half to control. The participants in the intervention group will, after the first clinical examination, pass on directly to the intervention which includes an allergological examination (patch and prick testing). Three days later they will be examined by a physician who will interpret the patch test and give a thorough, individual guidance in skin protection and occupational safety. The clinical examination of all participants at follow-up will reveal the difference in outcomes in the intervention and the control group.
| Study group | Role | What they receive |
|---|---|---|
| Hand Eczema in health care workers | No intervention | Not described Receives: Behavioral: A randomised clinical trial of the effect of classification and individual counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
Measured: 6 months
Secondary outcomes (1)
Secondary outcomes: -Subjective assessment of disease severity (HE) -Number of eruptions through the past three months -Knowledge of skin protection -Skinprotective behaviour -Quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Working Environment Authority, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012453
- Sponsor's protocol ID
- SJ-126
- Acronym
- HET
- Status last verified
- Nov 2009
- First submitted
- 12 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ibler KS, Jemec GB, Diepgen TL, Gluud C, Lindschou Hansen J, Winkel P, Thomsen SF, Agner T. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ. 2012 Dec 12;345:e7822. doi: 10.1136/bmj.e7822.
PubMed 23236031Ibler KS, Agner T, Hansen JL, Gluud C. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema. BMC Dermatol. 2010 Aug 31;10:8. doi: 10.1186/1471-5945-10-8.
PubMed 20807407
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Eczema Trial: A Randomised Clinical Trial of the Effect of Classification and Individual Counselling Among Health Care Workers With Hand Eczema
- ClinicalTrials.gov ID
- NCT01012453
- Acronym / sponsor ID
- HET / SJ-126
- Conditions
- Eczema, Dermatitis, Skin Disease
- Keywords
- Hand eczema, Hand dermatitis, Occupational skin disease, skindisease in health care workers, occupational hand dermatitis, occupational hand eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- The Danish Working Environment Authority, Region Zealand
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- First posted
- 13 Nov 2009 (estimated)
- 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.
Objectives and perspective:
- To estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . To investigate the knowledge of skin protection among health care workers.
- To classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema
- To evaluate the effect of a combination of classification of hand eczema and individual work-related counseling in skin protective behavior.
The overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers.
Hypotheses:
- Irritant contact dermatitis is more common than allergic contact dermatitis.
- The combination of precise classification (subtyping of HE) and individual counseling will have a positive impact on the prognosis of hand eczema.
- The positive impact on the prognosis of hand eczema will have a positive impact on quality of life (QoL).
- The knowledge of protective behavior will increase.
- Education in a skin care program will have a positive impact on skin protective behavior.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand Eczema in health care workers | No intervention | Behavioral: A randomised clinical trial of the effect of classification and individual counselling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
- Informed written consent must be present in order to participate.
Key exclusion criteria (6 listed)
- Pregnancy
- Systemic use of immunosuppressive drugs
- Systemic use of retinoids
- Active psoriatic lesions on the hands
- Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
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 |
|---|---|---|
| A randomised clinical trial of the effect of classification and individual counsellingThe trial to be conducted is a randomised single-blinded parallel study. It is divided in two stages, T = 0 and follow-up at T = 6 months. All included participants will have a clinical examination at the beginning and at follow-up in the trial. Half of the participants will be randomised to intervention, the other half to control. The participants in the intervention group will, after the first clinical examination, pass on directly to the intervention which includes an allergological examination (patch and prick testing). Three days later they will be examined by a physician who will interpret the patch test and give a thorough, individual guidance in skin protection and occupational safety. The clinical examination of all participants at follow-up will reveal the difference in outcomes in the intervention and the control group. | Behavioural | Hand Eczema in health care workers |
Primary outcome
Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
Time frame: 6 months
1 secondary outcome
Secondary outcomes: -Subjective assessment of disease severity (HE) -Number of eruptions through the past three months -Knowledge of skin protection -Skinprotective behaviour -Quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
- Derived from this study: PubMed 23236031Ibler KS, Jemec GB, Diepgen TL, Gluud C, Lindschou Hansen J, Winkel P, Thomsen SF, Agner T. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ. 2012 Dec 12;345:e7822. doi: 10.1136/bmj.e7822.
- Derived from this study: PubMed 20807407Ibler KS, Agner T, Hansen JL, Gluud C. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema. BMC Dermatol. 2010 Aug 31;10:8. doi: 10.1186/1471-5945-10-8.
Related trials for Eczema
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Tove Agner, MD, DM Science contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A randomised clinical trial of the effect of classification and individual counselling in people with Eczema and Dermatitis, run by Zealand University Hospital at 3 sites 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Sophie Ibler, MD, Ph.d-student (+45-47322600, ksi@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0. (time frame: 6 months). 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 NCT01012453, which also lists 2 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 13 Nov 2009.