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

This study has been completed.
Sponsor:
Collaborator:
Smerud Medical Research International AS
Information provided by:
ACO Hud Nordic AB
ClinicalTrials.gov Identifier:
NCT00576550
First received: December 18, 2007
Last updated: October 10, 2008
Last verified: December 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema

Resource links provided by NLM:

MedlinePlus related topics: Eczema
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
Experimental: 1:1
Part 1 of the study (maintenance part)
 Drug: Urea
Urea cream applied twice daily up to six months
Other Name: Canoderm 5% kräm
No Intervention: 1:2
Part 1 of the study (maintenance part)
Experimental: 2:1
Part 2 of the study (eczema part)
 Drug: betamethasone valerate
Application once daily for two weeks
Other Name: Betnoderm 0,1 % kräm
Active Comparator: 2:2
Part 2 of the study (eczema part)
 Drug: betamethasone valerate
Application twice daily for two weeks
Other Name: Betnoderm 0,1 % kräm

  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
Medi 3 Innlandet
Hamar, Norway
Dr Funks hudklinikk
Oslo, Norway
Colosseumklinikken
Oslo, 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: Karin Wirén, ACO HUD NORDIC
ClinicalTrials.gov Identifier: NCT00576550     History of Changes
Other Study ID Numbers: SMR-1588
Study First Received: December 18, 2007
Last Updated: October 10, 2008
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

Keywords provided by ACO Hud Nordic AB:
Hand eczema
Prevention

Additional relevant MeSH terms:
Eczema
Recurrence
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Disease Attributes
Pathologic Processes
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Emollients
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013