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

Primary Purpose

Hand Eczema

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Urea
betamethasone valerate
betamethasone valerate
Sponsored by
ACO Hud Nordic AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand Eczema focused on measuring Hand eczema, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medi 3 Innlandet
  • Colosseumklinikken
  • Dr Funks hudklinikk

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Active Comparator

Arm Label

1:1

1:2

2:1

2:2

Arm Description

Part 1 of the study (maintenance part)

Part 1 of the study (maintenance part)

Part 2 of the study (eczema part)

Part 2 of the study (eczema part)

Outcomes

Primary Outcome Measures

Time to relapse of hand eczema

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2007
Last Updated
October 10, 2008
Sponsor
ACO Hud Nordic AB
Collaborators
Smerud Medical Research International AS
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1. Study Identification

Unique Protocol Identification Number
NCT00576550
Brief Title
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
Official Title
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ACO Hud Nordic AB
Collaborators
Smerud Medical Research International AS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Eczema
Keywords
Hand eczema, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:1
Arm Type
Experimental
Arm Description
Part 1 of the study (maintenance part)
Arm Title
1:2
Arm Type
No Intervention
Arm Description
Part 1 of the study (maintenance part)
Arm Title
2:1
Arm Type
Experimental
Arm Description
Part 2 of the study (eczema part)
Arm Title
2:2
Arm Type
Active Comparator
Arm Description
Part 2 of the study (eczema part)
Intervention Type
Drug
Intervention Name(s)
Urea
Other Intervention Name(s)
Canoderm 5% kräm
Intervention Description
Urea cream applied twice daily up to six months
Intervention Type
Drug
Intervention Name(s)
betamethasone valerate
Other Intervention Name(s)
Betnoderm 0,1 % kräm
Intervention Description
Application once daily for two weeks
Intervention Type
Drug
Intervention Name(s)
betamethasone valerate
Other Intervention Name(s)
Betnoderm 0,1 % kräm
Intervention Description
Application twice daily for two weeks
Primary Outcome Measure Information:
Title
Time to relapse of hand eczema
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gro Moerk, MD
Organizational Affiliation
Rikshospitalet, Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medi 3 Innlandet
City
Hamar
Country
Norway
Facility Name
Colosseumklinikken
City
Oslo
Country
Norway
Facility Name
Dr Funks hudklinikk
City
Oslo
Country
Norway

12. IPD Sharing Statement

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

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