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
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Dermatitis, Atopic
- Sponsor
- LEO Pharma
- Enrollment
- 250
- Primary Endpoint
- Time to relapse in the maintenance phase (MP)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Arm 2
Intervention: Placebo
Arm 1
Intervention: Methylprednisolone Aceponate (Advantan, BAY86-4862)
Outcomes
Primary Outcomes
Time to relapse in the maintenance phase (MP)
Time Frame: Week 16
Secondary Outcomes
- 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)