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

Last updated: October 10, 2008
Sponsor: ACO Hud Nordic AB
Overall Status: Completed

Phase

3

Condition

Eczema (Atopic Dermatitis - Pediatric)

Rash

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT00576238
ACO/02/08
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 lesionscorresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6on 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

Exclusion Criteria:

  • Eczematous regions exclusively in intertriginous areas or in the face

  • Use of topical steroids or any other dermatologic drug therapy (moisturising creamsallowed) 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 relatedactivities

  • Factors suggesting low compliance with study procedures

  • Possible allergy to ingredients in the study medications

  • Pregnancy or breast feeding

Study Design

Total Participants: 55
Study Start date:
January 01, 2004
Estimated Completion Date:
February 29, 2008

Connect with a study center

  • Nacka hudmottagning

    Nacka, 13183
    Sweden

    Site Not Available

  • Nacka närsjukhus

    Nacka, 13183
    Sweden

    Site Not Available

  • Hudkliniken, Danderyds sjukhus

    Stockholm, 18288
    Sweden

    Site Not Available

  • Sophiahemmet

    Stockholm, 11486
    Sweden

    Site Not Available

  • Läkarhuset Vällingby

    Vällingby, 16862
    Sweden

    Site Not Available

  • Läkarhuset Vällingby

    Vällingby, 16862
    Sweden

    Site Not Available

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