Topical steroid creams as well as moisturising creams are important parts of the treatment strategy of atopic eczema. This study aims to investigare 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 moisturising cream on skin that has been previously cleared from eczema.

Official Title

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.

Conditions

  • Atopic Eczema

Study Type

Interventional

Study Design

Further Details

Primary Outcome Measures:

  • To study the compatibility of the skin with the new formulation in comparison to the reference medication.
    [Time Frame: 3 weeks]
    [Designated as safety issue: Yes]
  • To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
    [Time Frame: Up to 6 months]
    [Designated as safety issue: No]

Secondary Outcome Measures:

  • To study cosmetic acceptance of the corticosteroids
    [Time Frame: 3 weeks]
    [Designated as safety issue: No]
  • To study the safety of corticosteroid treatment.
    [Time Frame: 3 weeks]
    [Designated as safety issue: Yes]
  • To study the safety of maintenance treatment.
    [Time Frame: Up to 6 months.]
    [Designated as safety issue: Yes]

Study Start

January 2004

Eligibility & Criteria

  • Ages Eligible for Study: 18 – 65 years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

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

Total Enrolment

55

Contact Details

Hudkliniken, Danderyds sjukhus   
STOCKHOLM
Sweden, 18288