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

October 10, 2008 updated by: ACO Hud Nordic AB
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Hamar, Norway
        • Medi 3 Innlandet
      • Oslo, Norway
        • Colosseumklinikken
      • Oslo, Norway
        • Dr Funks hudklinikk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to relapse of hand eczema
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACO Hud Nordic AB

Collaborators

Smerud Medical Research International AS

Investigators

  • Principal Investigator: Gro Moerk, MD, Rikshospitalet, Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 13, 2008

Last Update Submitted That Met QC Criteria

October 10, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMR-1588

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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