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

NCT ID: NCT00576550

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-05-31

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.

Detailed Description

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Conditions

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Hand Eczema

Keywords

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Hand eczema Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1:1

Part 1 of the study (maintenance part)

Group Type EXPERIMENTAL

Urea

Intervention Type DRUG

Urea cream applied twice daily up to six months

1:2

Part 1 of the study (maintenance part)

Group Type NO_INTERVENTION

No interventions assigned to this group

2:1

Part 2 of the study (eczema part)

Group Type EXPERIMENTAL

betamethasone valerate

Intervention Type DRUG

Application once daily for two weeks

2:2

Part 2 of the study (eczema part)

Group Type ACTIVE_COMPARATOR

betamethasone valerate

Intervention Type DRUG

Application twice daily for two weeks

Interventions

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Urea

Urea cream applied twice daily up to six months

Intervention Type DRUG

betamethasone valerate

Application once daily for two weeks

Intervention Type DRUG

betamethasone valerate

Application twice daily for two weeks

Intervention Type DRUG

Other Intervention Names

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Canoderm 5% kräm Betnoderm 0,1 % kräm Betnoderm 0,1 % kräm

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smerud Medical Research International AS

OTHER

Sponsor Role collaborator

ACO Hud Nordic AB

INDUSTRY

Sponsor Role lead

Responsible Party

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ACO HUD NORDIC

Principal Investigators

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Gro Moerk, MD

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet, Oslo

Locations

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Medi 3 Innlandet

Hamar, , Norway

Site Status

Colosseumklinikken

Oslo, , Norway

Site Status

Dr Funks hudklinikk

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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SMR-1588

Identifier Type: -

Identifier Source: org_study_id