Atopic Dermatitis
Conditions
Brief summary
• Time to relapse of eczema (patient reported outcome [PRO]) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first
Detailed description
• Time to relapse of eczema (PRO) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS), • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS) per time, • Frequency of adverse events during the maintenance phase
Interventions
DRUGUrea/propylene glycol 50 mg/g + 250 mg/g cream
DRUGOviderm 250 mg/g kräm
Sponsors
Galenica AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Time to relapse of eczema (patient reported outcome [PRO]) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to relapse of eczema (PRO) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS), • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS) per time, • Frequency of adverse events during the maintenance phase | — |
Countries
Norway, Sweden
Outcome results
None listed