Chronic Hand EczemaNCT01482663
Chronic Hand Eczema - Self-management and Prognosis
A study testing Healthy Skin Clinic in people with Chronic Hand Eczema and Chronic Hand Dermatitis, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial summary
Hand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hand Eczema, Chronic Hand Dermatitis
- What is being tested?
- Healthy Skin Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2011to Dec 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinically diagnosed with hand eczema at the first medical consultation at the outpatient ward, Copenhagen University Hospital Gentofte or at a private dermatologic practise in Aalborg, Denmark
- Patients who have given a signed informed consent to participate
Who cannot join
- Patients who cannot reply to a questionnaire in Danish
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dermatologic practise, Vesterbro 99
Aalborg, 9000
Department of Dermato-Allergology, Copenhagen University Hospital Gentofte
Hellerup, 2900
About this study
Hand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Better methods to support self-management of patients with chronic hand eczema may potentially improve the prognosis of a disease which is both a tremendous burden to the individual and to the society. The purpose of this trial is to evaluate the effect of a newly designed guidance programme offering individual counselling compared to conventional information with written information sheets.
Read the detailed description
Detailed description of the trial and the intervention can be found in the publication:
Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial'. BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.
PMID: 22691871 [PubMed - indexed for MEDLINE] Free PMC Article
- Conditions
- Chronic Hand Eczema, Chronic Hand Dermatitis
- Being tested
- Healthy Skin Clinic
- Keywords
- Hand eczema, Hand dermatitis, Chronic hand eczema, Chronic hand dermatitis, Contact dermatitis, Skin disease, Self-management
- Medical subject headings
- Dermatitis, Contact, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Skin ClinicBehavioural
The intervention is founded upon three concurrent elements. Firstly, a SKIN-profile generated by data from a baseline questionnaire (S=Susceptibility, K=Competencies, I=Individual characteristics, N=Necessary precautions).
Secondly, a patient self-management book which includes a patient's log and is offered in both an online and a physical form. Also support to self-management is offered through possible asynchronous communication and networking.
Finally, a counselling consultation with a nurse, trained within dermatology.
| Study group | Role | What they receive |
|---|---|---|
| Chronic hand eczema patients | No intervention | Written information sheets and a 14-minutes DVD about hand eczema handed out by the dermatologist |
| Behavioral: Healthy Skin Clinic | Experimental | 1-2 counselling sessions with a nurse, tailored according to individual risks and resources and user access to a website comprising a self-monitoring log, a patients' forum and the possibility of communication with the intervention team of nurses Receives: Behavioral: Healthy Skin Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Eczema Severity Index (HECSI)
Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
Measured: 6 months
Secondary outcomes (3)
Dermatology Life Quality Index (DLQI)
DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.
Measured: 6 months
Overall burden of disease (VAS)
VAS measured by questionnaire at time = 6 months versus VAS measured by questionnaire at time = 0.
Measured: 6 months
Danish version of The Medication Adherence Report Scale (DMARS-4)
DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.
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 posted30 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Annette Mollerup, University Hospital, Gentofte, Copenhagen
- Investigators
- Annette Mollerup, MScHealth, Principal investigator, University Hospital, Gentofte, CopenhagenJeanne D Johansen, Prof, DMSc, Study director, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482663
- Sponsor's protocol ID
- CHE-2011-Geh
- Status last verified
- Dec 2014
- First submitted
- 23 Nov 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mollerup A, Veien NK, Johansen JD. Effectiveness of the Healthy Skin Clinic--a randomized clinical trial of nurse-led patient counselling in hand eczema. Contact Dermatitis. 2014 Oct;71(4):202-14. doi: 10.1111/cod.12243. Epub 2014 Apr 25.
PubMed 24766387Mollerup A, Veien NK, Johansen JD. An analysis of gender differences in patients with hand eczema - everyday exposures, severity, and consequences. Contact Dermatitis. 2014 Jul;71(1):21-30. doi: 10.1111/cod.12206. Epub 2014 Mar 12.
PubMed 24618009Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial. BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.
PubMed 22691871
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Hand Eczema - Self-management and Prognosis
- ClinicalTrials.gov ID
- NCT01482663
- Acronym / sponsor ID
- CHE-2011-Geh
- Conditions
- Chronic Hand Eczema, Chronic Hand Dermatitis
- Keywords
- Hand eczema, Hand dermatitis, Chronic hand eczema, Chronic hand dermatitis, Contact dermatitis, Skin disease, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Nov 2011 (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.
Hand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Better methods to support self-management of patients with chronic hand eczema may potentially improve the prognosis of a disease which is both a tremendous burden to the individual and to the society. The purpose of this trial is to evaluate the effect of a newly designed guidance programme offering individual counselling compared to conventional information with written information sheets.
Detailed description
Detailed description of the trial and the intervention can be found in the publication:
Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial'. BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.
PMID: 22691871 [PubMed - indexed for MEDLINE] Free PMC Article
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic hand eczema patients | No intervention | –Written information sheets and a 14-minutes DVD about hand eczema handed out by the dermatologist |
| Behavioral: Healthy Skin Clinic | Experimental | Behavioral: Healthy Skin Clinic1-2 counselling sessions with a nurse, tailored according to individual risks and resources and user access to a website comprising a self-monitoring log, a patients' forum and the possibility of communication with the intervention team of nurses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients clinically diagnosed with hand eczema at the first medical consultation at the outpatient ward, Copenhagen University Hospital Gentofte or at a private dermatologic practise in Aalborg, Denmark
- Patients who have given a signed informed consent to participate
Key exclusion criteria (1 listed)
- Patients who cannot reply to a questionnaire in Danish
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 |
|---|---|---|
| Healthy Skin ClinicThe intervention is founded upon three concurrent elements. Firstly, a SKIN-profile generated by data from a baseline questionnaire (S=Susceptibility, K=Competencies, I=Individual characteristics, N=Necessary precautions). Secondly, a patient self-management book which includes a patient's log and is offered in both an online and a physical form. Also support to self-management is offered through possible asynchronous communication and networking. Finally, a counselling consultation with a nurse, trained within dermatology. | Behavioural | Behavioral: Healthy Skin Clinic |
Primary outcome
Hand Eczema Severity Index (HECSI)
Time frame: 6 months
Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
3 secondary outcomes
Dermatology Life Quality Index (DLQI)
Time frame: 6 months
Overall burden of disease (VAS)
Time frame: 6 months
Danish version of The Medication Adherence Report Scale (DMARS-4)
Time frame: 6 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 3 Dec 2014.
- Results publication: PubMed 24766387Mollerup A, Veien NK, Johansen JD. Effectiveness of the Healthy Skin Clinic--a randomized clinical trial of nurse-led patient counselling in hand eczema. Contact Dermatitis. 2014 Oct;71(4):202-14. doi: 10.1111/cod.12243. Epub 2014 Apr 25.
- Results publication: PubMed 24618009Mollerup A, Veien NK, Johansen JD. An analysis of gender differences in patients with hand eczema - everyday exposures, severity, and consequences. Contact Dermatitis. 2014 Jul;71(1):21-30. doi: 10.1111/cod.12206. Epub 2014 Mar 12.
- Derived from this study: PubMed 22691871Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial. BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.
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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.
Annette Mollerup, MScHealth principal investigator
University Hospital, Gentofte, Copenhagen
Jeanne D Johansen, Prof, DMSc study director
University Hospital, Gentofte, Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Skin Clinic in people with Chronic Hand Eczema and Chronic Hand Dermatitis, run by University Hospital, Gentofte, Copenhagen at 2 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 1 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Hand Eczema Severity Index (HECSI) (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 NCT01482663, which also lists 3 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 3 Dec 2014.