Mild to moderate atopic dermatitis
Conditions
Brief summary
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)
Detailed description
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 week 3 (EOT), Patient´s assessment of severity of pruritus at visits (Visit 1, Visit 2, Visit 3 and Visit 4)
Interventions
DRUGVehicle to Methylprednisolone Aceponate Cream
DRUGMethylprednisolone Aceponate Cream
DRUGAdvantan 0.1% cream
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 week 3 (EOT), Patient´s assessment of severity of pruritus at visits (Visit 1, Visit 2, Visit 3 and Visit 4) | — |
Countries
Germany
Outcome results
None listed