Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Advantan 0,1% Salbe
Product Name: Advantan 0,1% Salbe
Pharmaceutical Form: Ointment
INN or Proposed INN: METHYLPREDNISOLONE ACEPONATE
CAS Number: 86401-95-8
Current Sponsor code: n.a.
Othe
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women, men and children/adolescents of both sexes = 6 years of age • Written consent to study participation after patient information by the investigator • In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and child/adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator • Acute flare of atopic dermatitis according to the investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate)) • Affected body surface (BSA) between at least 10% and not more than 40% • For women of childbearing potential : Application of an established highly efficient contraceptive method during the whole study • For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start Are the trial subjects under 18? yes Number of subjects for this age range: 330 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion • Any topical treatment (e.g. topical immunomodulators such as tacrolimus ointment, pimecrolimus cream, topical antibiotics, topical glucocorticoids, other topical anti-inflammatory medication) or physical therapy (e.g. UV radiation) of the atopic dermatitis in the test area 2 weeks prior to study inclusion • Presence of tuberculous or syphilitic processes in the treatment area • Presence of viral infections (such as herpes or varicella), rosacea, perioral dermatitis, ulcera, acne vulgaris, atrophic skin diseases and vaccination skin reactions in the area to be treated. • Presence of bacterial and/or mycotic skin diseases in the treatment area • Current diagnosis of glaucoma or cataract • Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication • Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations • Severe acute or chronic concomitant disease with severe impairment of the general condition • Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data • Reasonable doubt concerning the co-operation of the patient • Participation in another clinical study within the last 30 days prior to inclusion in this study • Participation in this study at an earlier date • Women with existing or intended pregnancy or during lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of efficacy and safety of a new methylprednisolone aceponate 0.1% ointment in comparison with the approved preparation Advantan 0.1% Ointment and the underlying vehicle in patients with mild to moderate atopic dermatitis.;Secondary Objective: • Percent change of Eczema Area and Severity Index (EASI) between visits • Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT) • Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT) • Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT) • Patient´s assessment of severity of pruritus ;Primary end point(s): The Primary endpoint of the study is the percent change from baseline (Visit 1) to Visit 4 (EOT) assessed by Eczema Area and Severity Index Score (EASI Score).;Timepoint(s) of evaluation of this end point: Start of therapy (Day 0) and end of therapy (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent change of Eczema Area and Severity Index Score (EASI Score) between baseline (Visit 1) and Visit 2 and Visit 3. • Percent change of the total affected body surface area (BSA) between baseline (Visit 1) and Visit 2, Visit 3 and Visit 4 • Change of the Investigator`s Global Assessment (IGA) between baseline (Visit 1) and Visit 2, Visit 3 and Visit 4 • Evaluation of Overall Therapeutic Success by the investigator and patient at Visit 4 (EOT) • Patient´s assessment of severity of pruritus at visits (Visit 1, Visit 2, Visit 3 and Visit 4) ;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 above | — |
Countries
Germany
Contacts
Public ContactClinical Research Department
Dermapharm AG
Outcome results
None listed