Trial Condition(s):
Dermatitis, Atopic
Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
Bayer Identifier:
91424
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
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Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Time to relapse in the maintenance phase (MP)Timeframe: Week 16
Secondary Outcome
- Patients' number of relapses in the maintenance phaseTimeframe: Week 16
- Treatment success as assessed by Investigator Global Assessment (IGA) scoreTimeframe: Week 16
- Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI)Timeframe: Week 16
- Index lesion monitoringTimeframe: Week 16
- Change of disease during AP and MP as assessed by Patient Global AssessmentTimeframe: Week 16
- Visual assessment of signs of atrophyTimeframe: Week 16
- Ultrasound for measurement of skin thickness in selected sitesTimeframe: Up to week 16
- Dermatology Life Quality Index (CDLQI, DLQI)Timeframe: Week 16
- Adverse Event CollectionTimeframe: Week 16
Additional Information
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