Severe generalized atopic dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Trade Name: Geralen
Pharmaceutical Form: Capsule*
CAS Number: 484208
Other descriptive name: 5-Methoxypsoralen
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Sponsors
Division of Special and Environmental Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with severe generalized atopic dermatitis (SCORAD Score =45) older than 18 years Are the trial subjects under 18? no Number of subjects for this age range: 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: SCORAD Score <45 Pregnant and lactating women Patients with severe general diseases Abnormal UVA sensitivity Intake of photosensitizing drugs Local corticosteroid treatment < 2 weeks before entering the study Photo(chemo)therapy or systemic treatment for atopic dermatitis < 4 weeks before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the duration of remission after UVA 1 phototherapy versus 5-MOP UVA photochemotherapy for patients with severe generalized atopic dermatitis;Secondary Objective: Clinical response (reduction of SCORAD Score); Ig E and ECP (eosinophilic cationic protein) course; kumulative UVA doses and adverse events of UVA 1 phototherapy and 5-MOP UVA photochemotherapy ;Primary end point(s): SCORAD Score during the follow-up > 50% of the baseline value | — |
Countries
Austria
Outcome results
None listed