Trial Condition(s):

Dermatitis, Atopic

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

Bayer Identifier:

91424

ClinicalTrials.gov Identifier:

NCT00185510

EudraCT Number:

2004-002673-22

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
250
Trial Dates
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Phase
4
Could I receive a placebo?
Yes
Products
Advantan (Methylprednisolone Aceponate, BAY86-4862)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design