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

NCT00576550 | Completed Phase 4

• 1 other identifier: SMR-1588
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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

Keywords

Hand eczema; Prevention

Outcome Measures

Primary Outcomes (1)

• Time to relapse of hand eczema

  Up to 6 months

Secondary Outcomes (1)

• The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily

  2 weeks

Study Arms (4)

1:1

EXPERIMENTAL

Part 1 of the study (maintenance part)

Drug: Urea

1:2

NO INTERVENTION

Part 1 of the study (maintenance part)

2:1

EXPERIMENTAL

Part 2 of the study (eczema part)

Drug: betamethasone valerate

2:2

ACTIVE COMPARATOR

Part 2 of the study (eczema part)

Drug: betamethasone valerate

Interventions

Urea DRUG

Urea cream applied twice daily up to six months

Also known as: Canoderm 5% kräm

1:1

betamethasone valerate DRUG

Application once daily for two weeks

Also known as: Betnoderm 0,1 % kräm

2:1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically proven history of hand eczema
• Daily use of moisturising treatment
• Either gender
• Age 18 or above
• Written Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• ACO Hud Nordic AB: lead
• Smerud Medical Research International AS: collaborator

Study Sites (3)

Medi 3 Innlandet

Hamar, Norway

Location

Colosseumklinikken

Oslo, Norway

Location

Dr Funks hudklinikk

Oslo, Norway

Location

MeSH Terms

Interventions

Urea; Betamethasone Valerate

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gro Moerk, MD

  Rikshospitalet, Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 19, 2007
• Study Start: October 1, 2007
• Study Completion: May 1, 2008
• Last Updated: October 13, 2008

Record last verified: 2007-12

Locations

NO (3)