Atopic dermatitis MedDRA version: 7.1 Level: PT Classification code 10012438
Conditions
Interventions
Trade Name: Advantan Ointment 0,1 %
Product Name: Advantan ointment
Product Code: SH S 440 A
Pharmaceutical Form: Ointment
INN or Proposed INN: Methylprednisolone aceponate
CAS Number: 86401-95-8
Curr
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute flare of atopic dermatitis according to the Investigator’s Global Assessment (IGA >= 4) ‘Severe’ or ‘Very Severe’ History of moderate to severe form of atopic dermatitis for at least one year Age of 2 – 15 years at baseline Affected Body Surface Area (BSA): minimum of 5% Wash out periods to be observed before start of study medication: At least 4 weeks have passed since any use of systemic therapy for atopic dermatitis (AD) At last 4 weeks have passed since any vaccination At least 4 weeks have passed since local AD therapy using protopic or elidel At least 2 weeks have passed since antihistaminic therapy At least 1 week has passed since local AD therapy using corticosteroids Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Indication for systemic therapy of the atopic dermatitis Known sensitivity to advantan, neribas, or protopic and / or to any excipients of the respective formulations Known sensitivity to macrolides Lymphadenopathy Known immune deficiency Known hepatic insufficiency Known renal insufficiency Acute herpes simplex, mononucleosis, 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) Generalized erythroderma, Netherton’s syndrome, Any conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study Patient is a dependent person, e.g., a relative / family member of the investigator and / or is a member of the investigator’s staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to compare the efficacy and safety of Advantan ointment applied once daily (plus application of Neribas for blinding reasons at second timepoint) for at least 2 weeks and not more than 3 weeks with the twice daily application of Protopic 0.03% ointment in children and adolescents with moderate to severe atopic dermatitis;Secondary Objective: Apart from the primary end point success rate, the following secondary end points will be described: Investigator’s Global Assessment Score (IGA) Modified Eczema Area and Severity Index (mEASI) Investigator’s Global Evaluation of Clinical response Patient’s assessment of global response Patient’s assessment of quality of sleep Children’s dermatology life quality index (CDLQI) (min. age 5 years) ;Primary end point(s): Investigator's Global Assessment (IGA) dichotomized as ‘success/failure’ by combining the scores in ‘Clear + Minimal’ and ‘Mild + Moderate + Severe + Very Severe’ at end of study medication. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed