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

Hand Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576550
• Other study ID #: SMR-1588
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2007
• Last updated: October 10, 2008
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: December 2007
• Source: ACO Hud Nordic AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Hand Eczema

Intervention

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

Locations

Country	Name	City	State
Norway	Medi 3 Innlandet	Hamar
Norway	Colosseumklinikken	Oslo
Norway	Dr Funks hudklinikk	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
ACO Hud Nordic AB	Smerud Medical Research International AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse of hand eczema		Up to 6 months	No
Secondary	The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily		2 weeks	No