This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
ACO Hud Nordic AB Identifier:
First received: December 18, 2007
Last updated: October 10, 2008
Last verified: October 2008
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
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

Resource links provided by NLM:

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 ]
  • 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:
  • To study cosmetic acceptance of the corticosteroids [ Time Frame: 3 weeks ]
  • To study the safety of corticosteroid treatment. [ Time Frame: 3 weeks ]
  • To study the safety of maintenance treatment. [ Time Frame: Up to 6 months. ]

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


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00576238

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
Principal Investigator: Berit Berne, MD Hudkliniken, Akademiska sjukhuset, Uppsala
  More Information

Responsible Party: Berit Berne, Hudkliniken, Akademiska sjukhuset, Uppsala Identifier: NCT00576238     History of Changes
Other Study ID Numbers: ACO/02/08
Study First Received: December 18, 2007
Last Updated: October 10, 2008

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

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Betamethasone benzoate
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents processed this record on September 21, 2017