Official Title: “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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Urea
  • Urea cream applied twice daily up to six months
• Drug: betamethasone valerate
  • Application once daily for two weeks
• Drug: betamethasone valerate
  • Application twice daily for two weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1:1
  • Part 1 of the study (maintenance part)
• No Intervention: 1:2
  • Part 1 of the study (maintenance part)
• Experimental: 2:1
  • Part 2 of the study (eczema part)
• Active Comparator: 2:2
  • Part 2 of the study (eczema part)

Primary Measures

• Time to relapse of hand eczema
  • Time Frame: Up to 6 months
    Safety Issue?: No

Secondary Measures

• The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily
  • Time Frame: 2 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: ACO Hud Nordic AB

Overall Clinical Trial Officials and Contacts

Gro Moerk, MD Principal Investigator Rikshospitalet, Oslo  

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576550

Study ID Number: SMR-1588

ClinicalTrials.gov Identifier: NCT00576550

Health Authority: Norway: Norwegian Medicines Agency