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

Primary Purpose

Atopic Eczema

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
betamethasone valerate
betamethasone valerate
urea
Sponsored by
ACO Hud Nordic AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Eczema focused on measuring Atopic eczema, Topical corticosteroid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nacka hudmottagning
  • Nacka närsjukhus
  • Sophiahemmet
  • Hudkliniken, Danderyds sjukhus
  • Läkarhuset Vällingby

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

1:1

1:2

2:1

2:2

Arm Description

Part 1 - eczema treatment

Part 1 - eczema treatment

Part 2 - maintenance treatment

Part 2 - maintenance treatment

Outcomes

Primary Outcome Measures

To study the compatibility of the skin with the new formulation in comparison to the reference medication.
To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.

Secondary Outcome Measures

To study cosmetic acceptance of the corticosteroids
To study the safety of corticosteroid treatment.
To study the safety of maintenance treatment.

Full Information

First Posted
December 18, 2007
Last Updated
October 10, 2008
Sponsor
ACO Hud Nordic AB
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1. Study Identification

Unique Protocol Identification Number
NCT00576238
Brief Title
Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ACO Hud Nordic AB

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Eczema
Keywords
Atopic eczema, Topical corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:1
Arm Type
Experimental
Arm Description
Part 1 - eczema treatment
Arm Title
1:2
Arm Type
Active Comparator
Arm Description
Part 1 - eczema treatment
Arm Title
2:1
Arm Type
Experimental
Arm Description
Part 2 - maintenance treatment
Arm Title
2:2
Arm Type
No Intervention
Arm Description
Part 2 - maintenance treatment
Intervention Type
Drug
Intervention Name(s)
betamethasone valerate
Other Intervention Name(s)
Betnoderm 0,1 % kräm
Intervention Description
Topical application according to a fixed schedule for three weeks
Intervention Type
Drug
Intervention Name(s)
betamethasone valerate
Other Intervention Name(s)
Betnovat kräm 0,1%
Intervention Description
Topical application according to a fixed schedule for three weeks
Intervention Type
Drug
Intervention Name(s)
urea
Other Intervention Name(s)
Canoderm kräm 5%
Intervention Description
Topical application twice daily for up to 6 months
Primary Outcome Measure Information:
Title
To study the compatibility of the skin with the new formulation in comparison to the reference medication.
Time Frame
3 weeks
Title
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 Measure Information:
Title
To study cosmetic acceptance of the corticosteroids
Time Frame
3 weeks
Title
To study the safety of corticosteroid treatment.
Time Frame
3 weeks
Title
To study the safety of maintenance treatment.
Time Frame
Up to 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Berne, MD
Organizational Affiliation
Hudkliniken, Akademiska sjukhuset, Uppsala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nacka hudmottagning
City
Nacka
ZIP/Postal Code
13183
Country
Sweden
Facility Name
Nacka närsjukhus
City
Nacka
ZIP/Postal Code
13183
Country
Sweden
Facility Name
Sophiahemmet
City
Stockholm
ZIP/Postal Code
11486
Country
Sweden
Facility Name
Hudkliniken, Danderyds sjukhus
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Läkarhuset Vällingby
City
Vällingby
ZIP/Postal Code
16862
Country
Sweden

12. IPD Sharing Statement

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

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