Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, prednisolone, ciclosporine, SCORAD, DLQI, QALY, WLQ
Brief summary
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.
Interventions
DRUGPrednisolone
DRUGCiclosporine A
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* male and female patients age \>= 18 and \< 55 * weight between 50 and 100 kg * confirmed diagnosis of AE (UK working party criteria) * objective SCORAD \> 40 * DLQI \> 10 * resistancy against topical treatment options including steroids and calcineurin-inhibitors
Exclusion criteria
* participation to another clinical trial within the last 4 weeks before baseline * pregnant or breastfeeding * women of childbearing potential without adequate contraception * allergy against prednisolone or Ciclosporine A * acute bacterial or viral infection * malignant tumor in personal history * diabetes mellitus * arterial hypertension * Glaucoma * peptic ulcer * severe osteoporosis * tuberculosis in personal history * colitis ulcerosa * diverticulitis * concurrent treatment with chloroquin, Mefloquin, Statins, Warafin * Creatinin Clearance \< 60 ml /min * UV treatment within 8 weeks before inclusion * ongoing systemic immunosuppressive treatment * planned vaccination within 8 weeks before study entry, during study and 2 weeks after end of study * Poliomyelitis * Lymphadenitis after BCG vaccination * Hyperuricaemia * chronic liver disease * Xeroderma pigmentosum, Cockaye-Syndrome, Bloom Syndrome * Psychiatric co-morbidity * drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| stable remission in both treatment groups | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse rate in both treatment groups | — |
| mean change in objective SCORAD in both treatment groups | — |
| mean change in HRQL (DLQI) in both treatment groups | — |
| change in disease symptoms (POEM)in both treatment groups | — |
| response rate in both treatment groups | — |
| Tolerability and Safety | — |
| change in presenteeism in both treatment groups | — |
| patient satisfaction | — |
| Cost-effectiveness of both treatments | — |
Countries
Austria, Germany
Outcome results
None listed