Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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 design
Primary purpose
Allocation
Interventional model
Masking
250 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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