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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014