Prednisolone vs. Ciclosporine in Severe Atopic Eczema

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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