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Completed

NCT Number: NCT00576550

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

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.

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Key information

Conditions

Hand Eczema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medi 3 Innlandet, Hamar, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urea

Drug

Urea cream applied twice daily up to six months

Other names: Canoderm 5% kräm

Betamethasone Valerate

Drug

Application once daily for two weeks

Other names: Betnoderm 0,1 % kräm

Primary outcomes

  1. Time to relapse of hand eczema

    Time frame: Up to 6 months

Secondary outcomes

  1. The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

ACO Hud Nordic AB

Industry

Collaborators

  • Smerud Medical Research International AS

Registry information

Important dates

Study start
2007
Study completion
2008
First posted
Dec 19, 2007
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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