Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser

October 10, 2008 updated by: ACO Hud Nordic AB

A Multi Centre, Parallel, Randomised Study of the Skin Tolerance of Betamethasone Creams on Atopic Eczema and the Influence of Moisturiser Treatment on the Recurrence of Eczema

Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. The second part of the study will investigate the possible preventative property of a moisturizing cream on skin that has been previously cleared from eczema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Nacka, Sweden, 13183
        • Nacka hudmottagning
      • Nacka, Sweden, 13183
        • Nacka närsjukhus
      • Stockholm, Sweden, 11486
        • Sophiahemmet
      • Stockholm, Sweden, 18288
        • Hudkliniken, Danderyds sjukhus
      • Vällingby, Sweden, 16862
        • Läkarhuset Vällingby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females and males between 18 and 65 years of age
  • Caucasian
  • AD according to the criteria of Hanifin and Rajka (12) with eczematous lesions corresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6 on any of the following areas: arms, legs, chest, abdomen or back
  • No serious health conditions that may interfere with the study
  • Written informed consent

Exclusion Criteria:

  • Eczematous regions exclusively in intertriginous areas or in the face
  • Use of topical steroids or any other dermatologic drug therapy (moisturising creams allowed) in the study area or light therapy within the preceding 2 weeks
  • Use of oral steroids within 1 month prior to the study
  • Use of concurrent medication e.g. medication that may interfere with the study related activities
  • Factors suggesting low compliance with study procedures
  • Possible allergy to ingredients in the study medications
  • Pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1:1
Part 1 - eczema treatment
Drug: betamethasone valerate
Topical application according to a fixed schedule for three weeks
Other Names:
  • Betnovat kräm 0,1%
Active Comparator: 1:2
Part 1 - eczema treatment
Drug: betamethasone valerate
Topical application according to a fixed schedule for three weeks
Other Names:
  • Betnovat kräm 0,1%
Experimental: 2:1
Part 2 - maintenance treatment
Drug: urea
Topical application twice daily for up to 6 months
Other Names:
  • Canoderm kräm 5%
No Intervention: 2:2
Part 2 - maintenance treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To study the compatibility of the skin with the new formulation in comparison to the reference medication.
Time Frame: 3 weeks
3 weeks
To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To study cosmetic acceptance of the corticosteroids
Time Frame: 3 weeks
3 weeks
To study the safety of corticosteroid treatment.
Time Frame: 3 weeks
3 weeks
To study the safety of maintenance treatment.
Time Frame: Up to 6 months.
Up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACO Hud Nordic AB

Investigators

  • Principal Investigator: Berit Berne, MD, Hudkliniken, Akademiska sjukhuset, Uppsala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 13, 2008

Last Update Submitted That Met QC Criteria

October 10, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACO/02/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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