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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. Identifier: NCT00576238
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : October 13, 2008
Information provided by:
ACO Hud Nordic AB

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.

Condition or disease Intervention/treatment Phase
Atopic Eczema Drug: betamethasone valerate Drug: urea Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2004
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 1:1
Part 1 - eczema treatment
Drug: betamethasone valerate
Topical application according to a fixed schedule for three weeks
Other Name: Betnoderm 0,1 % kräm

Active Comparator: 1:2
Part 1 - eczema treatment
Drug: betamethasone valerate
Topical application according to a fixed schedule for three weeks
Other Name: Betnovat kräm 0,1%

Experimental: 2:1
Part 2 - maintenance treatment
Drug: urea
Topical application twice daily for up to 6 months
Other Name: Canoderm kräm 5%

No Intervention: 2:2
Part 2 - maintenance treatment

Primary Outcome Measures :
  1. To study the compatibility of the skin with the new formulation in comparison to the reference medication. [ Time Frame: 3 weeks ]
  2. To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema. [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. To study cosmetic acceptance of the corticosteroids [ Time Frame: 3 weeks ]
  2. To study the safety of corticosteroid treatment. [ Time Frame: 3 weeks ]
  3. To study the safety of maintenance treatment. [ Time Frame: Up to 6 months. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576238

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Nacka hudmottagning
Nacka, Sweden, 13183
Nacka närsjukhus
Nacka, Sweden, 13183
Stockholm, Sweden, 11486
Hudkliniken, Danderyds sjukhus
Stockholm, Sweden, 18288
Läkarhuset Vällingby
Vällingby, Sweden, 16862
Sponsors and Collaborators
ACO Hud Nordic AB
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Principal Investigator: Berit Berne, MD Hudkliniken, Akademiska sjukhuset, Uppsala
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Responsible Party: Berit Berne, Hudkliniken, Akademiska sjukhuset, Uppsala Identifier: NCT00576238    
Other Study ID Numbers: ACO/02/08
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008
Keywords provided by ACO Hud Nordic AB:
Atopic eczema
Topical corticosteroid
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents