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

This study has been completed.
Sponsor:
Information provided by:
ACO Hud Nordic AB
ClinicalTrials.gov Identifier:
NCT00576238
First received: December 18, 2007
Last updated: October 10, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Atopic Eczema
 Drug: betamethasone valerate
Drug: urea
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Eczema Steroids
U.S. FDA Resources

Further study details as provided by ACO Hud Nordic AB:

Primary Outcome Measures:
  • To study the compatibility of the skin with the new formulation in comparison to the reference medication. [ Time Frame: 3 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study cosmetic acceptance of the corticosteroids [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To study the safety of corticosteroid treatment. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • To study the safety of maintenance treatment. [ Time Frame: Up to 6 months. ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: January 2004
Study Completion Date: February 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576238

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

No publications provided

Responsible Party: Berit Berne, Hudkliniken, Akademiska sjukhuset, Uppsala
ClinicalTrials.gov Identifier: NCT00576238     History of Changes
Other Study ID Numbers: ACO/02/08
Study First Received: December 18, 2007
Last Updated: October 10, 2008
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by ACO Hud Nordic AB:
Atopic eczema
Topical corticosteroid

Additional relevant MeSH terms:
Dermatitis, Atopic
Eczema
Skin Diseases, Genetic
Genetic Diseases, Inborn
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Betamethasone-17,21-dipropionate
 Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013