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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00576238
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : October 13, 2008
Sponsor:
Information provided by:
ACO Hud Nordic AB

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 19, 2007
Last Update Posted Date October 13, 2008
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
  • To study the compatibility of the skin with the new formulation in comparison to the reference medication. [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00576238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
  • To study cosmetic acceptance of the corticosteroids [ Time Frame: 3 weeks ]
  • To study the safety of corticosteroid treatment. [ Time Frame: 3 weeks ]
  • To study the safety of maintenance treatment. [ Time Frame: Up to 6 months. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Eczema
Intervention  ICMJE
  • 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%
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2007)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00576238
Other Study ID Numbers  ICMJE ACO/02/08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Berit Berne, Hudkliniken, Akademiska sjukhuset, Uppsala
Study Sponsor  ICMJE ACO Hud Nordic AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Berit Berne, MD Hudkliniken, Akademiska sjukhuset, Uppsala
PRS Account ACO Hud Nordic AB
Verification Date October 2008

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