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”

Topical steroid creams as well as moisturizing 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 moisturizing cream on skin that has been previously cleared from eczema.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: betamethasone valerate
  • Topical application according to a fixed schedule for three weeks
• Drug: betamethasone valerate
  • Topical application according to a fixed schedule for three weeks
• Drug: urea
  • Topical application twice daily for up to 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1:1
  • Part 1 - eczema treatment
• Active Comparator: 1:2
  • Part 1 - eczema treatment
• Experimental: 2:1
  • Part 2 - maintenance treatment
• No Intervention: 2:2
  • Part 2 - maintenance treatment

Primary Measures

• To study the compatibility of the skin with the new formulation in comparison to the reference medication.
  • Time Frame: 3 weeks
    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
    Safety Issue?: No

Secondary Measures

• To study cosmetic acceptance of the corticosteroids
  • Time Frame: 3 weeks
    Safety Issue?: No
• To study the safety of corticosteroid treatment.
  • Time Frame: 3 weeks
    Safety Issue?: Yes
• To study the safety of maintenance treatment.
  • Time Frame: Up to 6 months.
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: ACO Hud Nordic AB

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576238

Study ID Number: ACO/02/08

ClinicalTrials.gov Identifier: NCT00576238

Health Authority: Sweden: Medical Products Agency