A Randomised Trial of a Moisturising Cream in Preventing... | NCT00576550

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

NCT00576550

Sponsor

ACO Hud Nordic AB

Status

Completed

Last Update Posted

Oct 13, 2008Estimated

Enrollment

53Actual

Phase

Phase 4

Conditions

Hand Eczema

Interventions

Urea
betamethasone valerate
betamethasone valerate

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Dec 18, 2007

First Submission Date that Met QC Criteria

Dec 18, 2007

First Posted Date

Dec 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Name	Class
Smerud Medical Research International AS	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Urea	Drug	Urea cream applied twice daily up to six months	1:1	Canoderm 5% kräm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to relapse of hand eczema		Up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily		2 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gro Moerk, MD	Rikshospitalet, Oslo	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Medi 3 Innlandet		Hamar			Norway
Colosseumklinikken

Intervention Browse Module

MeSH Terms

ID	Term
D014508	Urea
D001624	Betamethasone Valerate

Ancestor Terms

ID	Term
D000577	Amides
D009930	Organic Chemicals
D001623	Betamethasone
D011246	Pregnadienetriols

Browse Leaves

Not provided

Browse Branches

Not provided