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Completed

NCT Number: NCT00576238

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

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.

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Key information

Conditions

Atopic Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nacka hudmottagning, Nacka, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone Valerate

Drug

Topical application according to a fixed schedule for three weeks

Other names: Betnoderm 0,1 % kräm

urea

Drug

Topical application twice daily for up to 6 months

Other names: Canoderm kräm 5%

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ACO Hud Nordic AB

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2008
First posted
Dec 19, 2007
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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