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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576550
First Posted: December 19, 2007
Last Update Posted: October 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Smerud Medical Research International AS
Information provided by:
ACO Hud Nordic AB
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily [ Time Frame: 2 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576550


Locations
Norway
Medi 3 Innlandet
Hamar, Norway
Colosseumklinikken
Oslo, Norway
Dr Funks hudklinikk
Oslo, Norway
Sponsors and Collaborators
ACO Hud Nordic AB
Smerud Medical Research International AS
Investigators
Principal Investigator: Gro Moerk, MD Rikshospitalet, Oslo
  More Information

Responsible Party: Karin Wirén, ACO HUD NORDIC
ClinicalTrials.gov Identifier: NCT00576550     History of Changes
Other Study ID Numbers: SMR-1588
First Submitted: December 18, 2007
First Posted: December 19, 2007
Last Update Posted: October 13, 2008
Last Verified: December 2007

Keywords provided by ACO Hud Nordic AB:
Hand eczema
Prevention

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