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

NCT ID: NCT00576550

Last Updated: 2008-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-05-31

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.

Conditions

Hand Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1:1

Part 1 of the study (maintenance part)

Group Type: EXPERIMENTAL

Urea

Intervention Type: DRUG

Urea cream applied twice daily up to six months

1:2

Part 1 of the study (maintenance part)

Group Type: NO_INTERVENTION

No interventions assigned to this group

2:1

Part 2 of the study (eczema part)

Group Type: EXPERIMENTAL

betamethasone valerate

Intervention Type: DRUG

Application once daily for two weeks

2:2

Part 2 of the study (eczema part)

Group Type: ACTIVE_COMPARATOR

betamethasone valerate

Intervention Type: DRUG

Application twice daily for two weeks

Interventions

Urea

Urea cream applied twice daily up to six months

Intervention Type: DRUG

betamethasone valerate

Application once daily for two weeks

Intervention Type: DRUG

betamethasone valerate

Application twice daily for two weeks

Intervention Type: DRUG

Other Intervention Names

Canoderm 5% kräm; Betnoderm 0,1 % kräm; Betnoderm 0,1 % kräm

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smerud Medical Research International AS

OTHER

Sponsor Role: collaborator

ACO Hud Nordic AB

INDUSTRY

Sponsor Role: lead

Responsible Party

ACO HUD NORDIC

Principal Investigators

Gro Moerk, MD

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet, Oslo

Locations

Medi 3 Innlandet

Hamar, , Norway

Colosseumklinikken

Oslo, , Norway

Dr Funks hudklinikk

Oslo, , Norway

Countries

Norway

Other Identifiers

SMR-1588

Identifier Type: -

Identifier Source: org_study_id