Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
Phase 4
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT00185510
- Lead Sponsor
- LEO Pharma
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Methylprednisolone Aceponate (Advantan, BAY86-4862) - Arm 2 Placebo -
- Primary Outcome Measures
Name Time Method Time to relapse in the maintenance phase (MP) Week 16
- Secondary Outcome Measures
Name Time Method Treatment success as assessed by Investigator Global Assessment (IGA) score Week 16 Index lesion monitoring Week 16 Change of disease during AP and MP as assessed by Patient Global Assessment Week 16 Ultrasound for measurement of skin thickness in selected sites Up to week 16 Patients' number of relapses in the maintenance phase Week 16 Visual assessment of signs of atrophy Week 16 Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI) Week 16 Dermatology Life Quality Index (CDLQI, DLQI) Week 16 Adverse Event Collection Week 16