Hand EczemaPhase 4NCT00576550
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
A Phase 4 study testing Urea and betamethasone valerate in people with Hand Eczema, run by ACO Hud Nordic AB at 3 sites in Norway.
Trial summary
The purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily. 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?
- Urea and betamethasone valerate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesNorway
- Study dates
- Oct 2007to May 2008
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically proven history of hand eczema
- At inclusion controlled state of hand eczema (≤3 on Hand Eczema Extent Score, HEES)
- Daily use of moisturising treatment
- Either gender
- Age 18 or above
- Written Informed Consent
Who cannot join
- Possible allergy to ingredients in the study medications
- At study start active psoriatic lesions or active atopic eczema lesions on the hands. Active bacterial, fungal or viral infection of the hands
- Patients who are pregnant or breast-feeding, or who plan to become pregnant during the course of the study
- Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy
- Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse)
- Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
- Inclusion in a study of an investigational drug within 60 days prior to start of treatment
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Medi 3 Innlandet
Hamar
Colosseumklinikken
Oslo
Dr Funks hudklinikk
Oslo
About this study
The purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily.
- Conditions
- Hand Eczema
- Being tested
- Urea, betamethasone valerate
- Keywords
- Hand eczema, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreaDrug
Also called Canoderm 5% kräm
Urea cream applied twice daily up to six months
betamethasone valerateDrug
Also called Betnoderm 0,1 % kräm
Application once daily for two weeks
betamethasone valerateDrug
Also called Betnoderm 0,1 % kräm
Application twice daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| 1:1 | Experimental | Part 1 of the study (maintenance part) Receives: Drug: Urea |
| 1:2 | No intervention | Part 1 of the study (maintenance part) |
| 2:1 | Experimental | Part 2 of the study (eczema part) Receives: Drug: betamethasone valerate |
| 2:2 | Active comparator | Part 2 of the study (eczema part) Receives: Drug: betamethasone valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse of hand eczema
Measured: Up to 6 months
Secondary outcomes (1)
The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startOct 2007
- Study completionMay 2008
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACO Hud Nordic AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS
- Investigators
- Gro Moerk, MD, Principal investigator, Rikshospitalet, Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576550
- Sponsor's protocol ID
- SMR-1588
- Status last verified
- Dec 2007
- First submitted
- 18 Dec 2007
- Last updated
- 13 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
- ClinicalTrials.gov ID
- NCT00576550
- Acronym / sponsor ID
- SMR-1588
- Conditions
- Hand Eczema
- Keywords
- Hand eczema, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- ACO Hud Nordic ABIndustry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS
- Study start
- Oct 2007
- Study completion
- May 2008 (actual)
- First posted
- 19 Dec 2007 (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.
The purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1:1 | Experimental | Drug: UreaPart 1 of the study (maintenance part) |
| 1:2 | No intervention | –Part 1 of the study (maintenance part) |
| 2:1 | Experimental | Drug: betamethasone valeratePart 2 of the study (eczema part) |
| 2:2 | Active comparator | Drug: betamethasone valeratePart 2 of the study (eczema part) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically proven history of hand eczema
- At inclusion controlled state of hand eczema (≤3 on Hand Eczema Extent Score, HEES)
- Daily use of moisturising treatment
- Either gender
- Age 18 or above
Key exclusion criteria (7 listed)
- Possible allergy to ingredients in the study medications
- At study start active psoriatic lesions or active atopic eczema lesions on the hands. Active bacterial, fungal or viral infection of the hands
- Patients who are pregnant or breast-feeding, or who plan to become pregnant during the course of the study
- Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy
- Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse)
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 |
|---|---|---|
| UreaAlso: Canoderm 5% krämUrea cream applied twice daily up to six months | Drug | 1:1 |
| betamethasone valerateAlso: Betnoderm 0,1 % krämApplication once daily for two weeks | Drug | 2:1 |
| betamethasone valerateAlso: Betnoderm 0,1 % krämApplication twice daily for two weeks | Drug | 2:2 |
Primary outcome
Time to relapse of hand eczema
Time frame: Up to 6 months
1 secondary outcome
The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily
Time frame: 2 weeks
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 13 Oct 2008.
Related trials for Hand Eczema
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingObservational study
PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry
Chronic Hand Eczema
Enrolling by invitationObservational study
Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
Chronic Hand Eczema (CHE)
RecruitingObservational study
Characterization of Chronic Hand Eczema
Chronic Hand Eczema, Atopic Dermatitis
Active, not recruitingObservational study
Methotrexat to Hand Eczema in the BIOSKIN Cohort
Atopic Dermatitis, Contact 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.
Gro Moerk, MD principal investigator
Rikshospitalet, Oslo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Urea and betamethasone valerate in people with Hand Eczema, run by ACO Hud Nordic AB at 3 sites in Norway.
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 6 inclusion and 7 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 13 Oct 2008. 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to relapse of hand eczema (time frame: Up to 6 months). 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 13 Oct 2008.