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

This study has been completed.

First Received: December 18, 2007 Last Updated: October 10, 2008 History of Changes

Sponsors and Collaborators:	ACO Hud Nordic AB Smerud Medical Research International AS
Information provided by:	ACO Hud Nordic AB
ClinicalTrials.gov Identifier:	NCT00576550

Purpose

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.

Condition	Intervention	Phase
Hand Eczema	Drug: Urea Drug: betamethasone valerate	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema

Resource links provided by NLM:

MedlinePlus related topics: Eczema

Drug Information available for: Carbamide Carbamide peroxide Bentelan Betamethasone Betamethasone dipropionate

U.S. FDA Resources

Further study details as provided by ACO Hud Nordic AB:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	53
Study Start Date:	October 2007
Study Completion Date:	May 2008

Arms	Assigned Interventions
1:1: Experimental Part 1 of the study (maintenance part)	Drug: Urea Urea cream applied twice daily up to six months
1:2: No Intervention Part 1 of the study (maintenance part)
2:1: Experimental Part 2 of the study (eczema part)	Drug: betamethasone valerate Application once daily for two weeks
2:2: Active Comparator Part 2 of the study (eczema part)	Drug: betamethasone valerate Application twice daily for two weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576550

Locations

Norway
Dr Funks hudklinikk
Oslo, Norway
Colosseumklinikken
Oslo, Norway
Medi 3 Innlandet
Hamar, Norway

Sponsors and Collaborators

ACO Hud Nordic AB

Smerud Medical Research International AS

Investigators

Principal Investigator:

Gro Moerk, MD

Rikshospitalet, Oslo

More Information

No publications provided

Responsible Party:	ACO HUD NORDIC ( Karin Wirén )
Study ID Numbers:	SMR-1588
Study First Received:	December 18, 2007
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00576550 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: The National Committees for Research Ethics in Norway; Norway: Data Inspectorate

Keywords provided by ACO Hud Nordic AB:

Hand eczema
Prevention

Study placed in the following topic categories:

Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Skin Diseases
Hormone Antagonists
Betamethasone sodium phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Skin Abnormalities
Anti-Asthmatic Agents
Eczema

Acrodermatitis
Hormones
Glucocorticoids
Recurrence
Sodium phosphate
Skin Diseases, Eczematous
Congenital Abnormalities
Betamethasone
Dermatitis

Additional relevant MeSH terms:

Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Respiratory System Agents
Skin Diseases
Betamethasone sodium phosphate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Skin Abnormalities
Anti-Asthmatic Agents
Eczema

Acrodermatitis
Hormones
Glucocorticoids
Pharmacologic Actions
Therapeutic Uses
Skin Diseases, Eczematous
Congenital Abnormalities
Betamethasone
Dermatitis

ClinicalTrials.gov processed this record on July 02, 2009