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

Study Overview
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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.

Official Title
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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

Conditions
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Atopic Eczema

Intervention / Treatment
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* Drug: betamethasone valerate
* Drug: betamethasone valerate
* Drug: urea


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1:1<br>Part 1 - eczema treatment | Drug: betamethasone valerate<br>* Topical application according to a fixed schedule for three weeks<br>* Other names: Betnoderm 0,1 % kräm;|
| Active Comparator: 1:2<br>Part 1 - eczema treatment | Drug: betamethasone valerate<br>* Topical application according to a fixed schedule for three weeks<br>* Other names: Betnovat kräm 0,1%;|
| Experimental: 2:1<br>Part 2 - maintenance treatment | Drug: urea<br>* Topical application twice daily for up to 6 months<br>* Other names: Canoderm kräm 5%;|
| No Intervention: 2:2<br>Part 2 - maintenance treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the compatibility of the skin with the new formulation in comparison to the reference medication. |  | 3 weeks | 
| To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema. |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study cosmetic acceptance of the corticosteroids |  | 3 weeks | 
| To study the safety of corticosteroid treatment. |  | 3 weeks | 
| To study the safety of maintenance treatment. |  | Up to 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic eczema, Topical corticosteroid