EUCTR2004-002673-22-DE
Active, not recruiting
Not Applicable
Double-blind, placebo controlled, randomized, multicenter, parallel-group study to compare the efficacy and safety of Advantan cream twice weekly with Advabas cream during a maintenance phase of 16 weeks after successful treatment of Atopic Dermatitis with Advantan cream - Advantan maintenance study
DrugsAdvantan Cream 0,1 %
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Schering AG
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be randomized, each patient must fulfill all of the inclusion criteria listed below.
- •1\. Fully informed written consent of the legal representative and assent of the patient
- •2\. Acute flare of atopic dermatitis according to the Investigator’s Global Assessment
- •(IGA \>\= 4\) ‘Severe’ or ‘Very Severe’
- •3\. History of moderate to severe form of atopic dermatitis for at least two years
- •4\. Age of 12 years at Screening or older
- •5\. Wash out periods to be observed before Baseline:
- •\- At least 4 weeks have passed since any use of systemic therapy for atopic dermatitis (AD), e. g., systemic corticosteroids (including inhaled or intranasal \> 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
- •\- At least 4 weeks have passed since any use of systemic AD therapy, e. g., systemic corticosteroids (including inhaled or intranasal \> 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
- •\- At last 4 weeks have passed since any vaccination
Exclusion Criteria
- •For scientific and safety reasons and in accordance with the respective product information, patients exhibiting any of the criteria below are to be excluded from the Study:
- •1\. Pregnancy, breast feeding
- •2\. Any conditions that could interfere with any evaluation in the study
- •3\. Indication for systemic AD therapy
- •4\. Known sensitivity to Advantan, Advabase and / or to any content of the respective formulations
- •5\. Known immune, hepatic, or renal insufficiency
- •6\. Acute herpes simplex or mollusca contagiosa infection
- •7\. Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
- •8\. Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
- •9\. Acute infestations (e.g. head lice, scabies)
Outcomes
Primary Outcomes
Not specified
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