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

This study has been completed.
Sponsor:
Information provided by:
ACO Hud Nordic AB
ClinicalTrials.gov Identifier:
NCT00576238
First received: December 18, 2007
Last updated: October 10, 2008
Last verified: October 2008
History of Changes

December 18, 2007
October 10, 2008
January 2004
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT00576238 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Eczema
  • Drug: betamethasone valerate
    Topical application according to a fixed schedule for three weeks
    Other Name: Betnoderm 0,1 % kräm
  • Drug: betamethasone valerate
    Topical application according to a fixed schedule for three weeks
    Other Name: Betnovat kräm 0,1%
  • Drug: urea
    Topical application twice daily for up to 6 months
    Other Name: Canoderm kräm 5%
  • Experimental: 1:1
    Part 1 - eczema treatment
    Intervention: Drug: betamethasone valerate
  • Active Comparator: 1:2
    Part 1 - eczema treatment
    Intervention: Drug: betamethasone valerate
  • Experimental: 2:1
    Part 2 - maintenance treatment
    Intervention: Drug: urea
  • No Intervention: 2:2
    Part 2 - maintenance treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
February 2008
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00576238
ACO/02/08
No
Berit Berne, Hudkliniken, Akademiska sjukhuset, Uppsala
ACO Hud Nordic AB
Not Provided
Principal Investigator: Berit Berne, MD Hudkliniken, Akademiska sjukhuset, Uppsala
ACO Hud Nordic AB
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP