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

Phase 4

Completed

• Conditions: Hand Eczema
• Interventions: Drug: Urea; Drug: betamethasone valerate

• Registration Number: NCT00576550
• Lead Sponsor: ACO Hud Nordic AB

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2007-12
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Study Completion: 2008-05
• Last Update Submitted: 2008-10-10
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1:1	Urea	Part 1 of the study (maintenance part)
2:1	betamethasone valerate	Part 2 of the study (eczema part)
2:2	betamethasone valerate	Part 2 of the study (eczema part)

Primary Outcome Measures

Name	Time	Method
Time to relapse of hand eczema	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily	2 weeks

Trial Locations

Locations (3)

Medi 3 Innlandet; 🇳🇴 Hamar, Norway

Colosseumklinikken; 🇳🇴 Oslo, Norway

Dr Funks hudklinikk; 🇳🇴 Oslo, Norway