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

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

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-06-30

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.

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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.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Methylprednisolone Aceponate (Advantan, BAY86-4862)

Intervention Type DRUG

In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 days a week Vehicle (Advabase)

Interventions

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Methylprednisolone Aceponate (Advantan, BAY86-4862)

In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.

Intervention Type DRUG

Placebo

2 days a week Vehicle (Advabase)

Intervention Type DRUG

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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No