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

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ClinicalTrials.gov Identifier: NCT00576238
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : October 13, 2008
Sponsor:
Information provided by:

Study Description
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

Study Design

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
Study Completion Date : February 2008


Arms and Interventions

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


Outcome Measures

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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00576238


Locations
Sweden
Nacka hudmottagning
Nacka, Sweden, 13183
Nacka närsjukhus
Nacka, Sweden, 13183
Sophiahemmet
Stockholm, Sweden, 11486
Hudkliniken, Danderyds sjukhus
Stockholm, Sweden, 18288
Läkarhuset Vällingby
Vällingby, Sweden, 16862
Sponsors and Collaborators
ACO Hud Nordic AB
Investigators
Principal Investigator: Berit Berne, MD Hudkliniken, Akademiska sjukhuset, Uppsala
More Information

Responsible Party: Berit Berne, Hudkliniken, Akademiska sjukhuset, Uppsala
ClinicalTrials.gov Identifier: NCT00576238     History of Changes
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:
Eczema
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents