Darier disease
Conditions
Brief summary
The primary endpoint will be a reduction of skin area affected using the 5-point Physician Global Assessment (PGA) scale (23). A 20 % reduction (1 point) will be considered the minimal clinically important difference.
Detailed description
As the main secondary endpoint, improvement in dermatological quality of life index (DLQI) will be used. A 4 points improvement in DLQI will be considered the minimal clinically important difference (24). We will also examine mood with the Montgomery–Åsberg Depression Rating Scale (MADRS) and treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM)., As complementary skin assessment tools we will use the Eczema Area and Severity Index (EASI) scale and Body Surface Area (BSA)., Number of adverse events and adverse reactions, serious and non-serious.
Interventions
DRUGDantrium Capsules 25mg
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be a reduction of skin area affected using the 5-point Physician Global Assessment (PGA) scale (23). A 20 % reduction (1 point) will be considered the minimal clinically important difference. | — |
Secondary
| Measure | Time frame |
|---|---|
| As the main secondary endpoint, improvement in dermatological quality of life index (DLQI) will be used. A 4 points improvement in DLQI will be considered the minimal clinically important difference (24). We will also examine mood with the Montgomery–Åsberg Depression Rating Scale (MADRS) and treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM)., As complementary skin assessment tools we will use the Eczema Area and Severity Index (EASI) scale and Body Surface Area (BSA)., Number of adverse events and adverse reactions, serious and non-serious. | — |
Countries
Sweden
Outcome results
None listed