Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis

Study Overview
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Brief Summary
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Purpose of the study: One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile to test modes how to efficiently prevent relapses or at least increase the time until the disease recurs. In order to give recommendations to other patients, this study is to scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy with two days a week Advantan.

Detailed Description
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The study has initially been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Intendis GmbH, a Bayer HealthCare company, is the sponsor of the trial.

Official Title
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Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis With Advantan Cream

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute 'Severe' or 'Very Severe' flare of atopic dermatitis; no minimum affected body surface History of moderate to severe form of atopic dermatitis for at least two years Exclusion Criteria: Pregnancy, breast feeding Known immune, hepatic, or renal insufficiency Acute herpes simplex or mollusca contagiosa infection Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis) Acute infestations (e.g. head lice, scabies)

Ages Eligible for Study
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Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)<br>* In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* 2 days a week Vehicle (Advabase)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse in the maintenance phase (MP) |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' number of relapses in the maintenance phase |  | Week 16 | 
| Treatment success as assessed by Investigator Global Assessment (IGA) score |  | Week 16 | 
| Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI) |  | Week 16 | 
| Index lesion monitoring |  | Week 16 | 
| Change of disease during AP and MP as assessed by Patient Global Assessment |  | Week 16 | 
| Visual assessment of signs of atrophy |  | Week 16 | 
| Ultrasound for measurement of skin thickness in selected sites |  | Up to week 16 | 
| Dermatology Life Quality Index (CDLQI, DLQI) |  | Week 16 | 
| Adverse Event Collection |  | Week 16 |