Prednisolone vs. Ciclosporine in Severe Atopic Eczema (PROVE)

Technische Universität Dresden

Status and phase

Completed

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Ciclosporine A

Drug: Prednisolone

Study type

Interventional

Funder types

Other

Identifiers

EudraCT-Nr:2006-003667-31

TUD_PROVE_001

Details and patient eligibility

About

To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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