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

NCT ID: NCT00576238

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Eczema

Keywords

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Atopic eczema Topical corticosteroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1:1

Part 1 - eczema treatment

Group Type EXPERIMENTAL

betamethasone valerate

Intervention Type DRUG

Topical application according to a fixed schedule for three weeks

1:2

Part 1 - eczema treatment

Group Type ACTIVE_COMPARATOR

betamethasone valerate

Intervention Type DRUG

Topical application according to a fixed schedule for three weeks

2:1

Part 2 - maintenance treatment

Group Type EXPERIMENTAL

urea

Intervention Type DRUG

Topical application twice daily for up to 6 months

2:2

Part 2 - maintenance treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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betamethasone valerate

Topical application according to a fixed schedule for three weeks

Intervention Type DRUG

betamethasone valerate

Topical application according to a fixed schedule for three weeks

Intervention Type DRUG

urea

Topical application twice daily for up to 6 months

Intervention Type DRUG

Other Intervention Names

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Betnoderm 0,1 % kräm Betnovat kräm 0,1% Canoderm kräm 5%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ACO Hud Nordic AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Hudkliniken, Akademiska sjukhuset, Uppsala

Principal Investigators

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Berit Berne, MD

Role: PRINCIPAL_INVESTIGATOR

Hudkliniken, Akademiska sjukhuset, Uppsala

Locations

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Nacka hudmottagning

Nacka, , Sweden

Site Status

Nacka närsjukhus

Nacka, , Sweden

Site Status

Sophiahemmet

Stockholm, , Sweden

Site Status

Hudkliniken, Danderyds sjukhus

Stockholm, , Sweden

Site Status

Läkarhuset Vällingby

Vällingby, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ACO/02/08

Identifier Type: -

Identifier Source: org_study_id