check_circleStudy Completed
Dermatitis, Atopic
Bayer Identifier:
91424
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
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.
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.
Key Participants Requirements
Sex
BothAge
12 YearsTrial summary
Enrollment Goal
250Trial Dates
March 2005 - June 2006Phase
Phase 4Could I Receive a placebo
YesProducts
Advantan (Methylprednisolone Aceponate, BAY86-4862)Accepts Healthy Volunteer
NoPrimary Outcome
- Time to relapse in the maintenance phase (MP)date_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Patients' number of relapses in the maintenance phasedate_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
- Treatment success as assessed by Investigator Global Assessment (IGA) scoredate_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
- Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)date_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
- Index lesion monitoringdate_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
- Change of disease during AP and MP as assessed by Patient Global Assessmentdate_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
- Visual assessment of signs of atrophydate_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
- Ultrasound for measurement of skin thickness in selected sitesdate_rangeTime Frame:Up to week 16enhanced_encryptionNoSafety Issue:
- Dermatology Life Quality Index (CDLQI, DLQI)date_rangeTime Frame:Week 16enhanced_encryptionNoSafety Issue:
- Adverse Event Collectiondate_rangeTime Frame:Week 16enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2