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

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

October 10, 2008

Start Date ^ICMJE

October 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time to relapse of hand eczema [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00576550 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hand Eczema

Intervention ^ICMJE

Drug: Urea
Drug: betamethasone valerate

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00576550

Responsible Party

Karin Wirén, ACO HUD NORDIC

Study ID Numbers ^ICMJE

SMR-1588

Study Sponsor ^ICMJE

ACO Hud Nordic AB

Collaborators ^ICMJE

Smerud Medical Research International AS

Investigators ^ICMJE

Principal Investigator:

Gro Moerk, MD

Rikshospitalet, Oslo

Information Provided By

ACO Hud Nordic AB

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP