A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema

Conditions
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Hand Eczema

Intervention / Treatment
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* Drug: Urea
* Drug: betamethasone valerate
* Drug: betamethasone valerate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1:1<br>Part 1 of the study (maintenance part) | Drug: Urea<br>* Urea cream applied twice daily up to six months<br>* Other names: Canoderm 5% kräm;|
| No Intervention: 1:2<br>Part 1 of the study (maintenance part) | |
| Experimental: 2:1<br>Part 2 of the study (eczema part) | Drug: betamethasone valerate<br>* Application once daily for two weeks<br>* Other names: Betnoderm 0,1 % kräm;|
| Active Comparator: 2:2<br>Part 2 of the study (eczema part) | Drug: betamethasone valerate<br>* Application twice daily for two weeks<br>* Other names: Betnoderm 0,1 % kräm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse of hand eczema |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand eczema, Prevention