Atopic Dermatitis MedDRA version: 12.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Name: Mapracorat
Product Code: ZK 245186
Pharmaceutical Form: Ointment
INN or Proposed INN: Mapracorat
CAS Number: 887375-26-0
Current Sponsor code: ZK 245186
Concentration unit: mg/g milligra
Sponsors
Intendis GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must fulfill all of the following criteria before inclusion in the study: 1 Signed written informed consent 2 Male or female out-patient subject 18 to 65 years of age at screening (female subject either using an accepted effective method of contraception (failure rate of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are to be excluded from the study if they display any of the following criteria: Medical and surgical history 1 Pregnancy or lactation 2 Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results 3 Clinically manifested immunosuppressive disorder or known history of malignant disease 4 Known hypersensitivity to any of the constituents or excipients of the investigational product (e.g. paraffin) or history of relevant drug and/or food allergies Medication, drug use and special behavioral patterns 5 Use of any prescription or non-prescription medication prior to baseline that could interfere with evaluations in the study • At least 3 months have passed since any systemic interferon, immunomodulating or immunosuppressive treatment (excluding systemic AD therapy as listed in the following point) • At least 1 month has passed since any use of systemic AD therapy, in particular systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy • At least 2 weeks have passed since any local AD therapy, e.g. corticosteroids or topical immunomodulators • At least 2 weeks have passed since systemic or topical antibiotics • At least 1 week has passed since use of local anti-itch therapy (for example atopiclair) Physical examination 6 Concomitant medical or dermatological disorder(s), which could interfere with the investigator’s ability to evaluate the subject’s response to the investigational product, e.g. chicken pox, impetigo, corticosteroid-induced perioral dermatitis, tinea corporis/tinea intertriginosa, recurrent active herpes simplex, head lice or scabies Laboratory examination 7 Clinically relevant deviation in values for biochemistry, hematology, coagulation or urinalysis as judged by the investigator Other 8 Mental handicap, legal incapacity or limited legal capacity leading to inability to give informed consent, subject is institutionalized because of legal or regulatory order 9 Subject is a dependent person, this means a relative/family member of the investigator and/or a member of the investigator’s staff 10 Participation in another clinical research study within 4 weeks before enrollment in this study. 11 Previous assignment to treatment during this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess the efficacy of mapracorat ointment in concentrations of 0.01%, 0.03%, and 0.1% in subjects with AD compared to vehicle. ;Secondary Objective: The secondary objectives of this study are: • To evaluate the safety and tolerability of mapracorat ointment in concentrations of 0.01%, 0.03%, and 0.1% • To assess the dose-response relationship of mapracorat after topical, non-occlusive application of concentrations of 0.01%, 0.03%, and 0.1% • To assess the systemic exposure of mapracorat after topical, non-occlusive application of concentrations of 0.01%, 0.03%, and 0.1% ;Primary end point(s): Primary end point is eczema area and severity index (EASI) | — |
Countries
Czech Republic, Germany, Hungary, Latvia
Outcome results
None listed