Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Phase 4

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Ciclosporine A; Drug: Prednisolone

• Registration Number: NCT00445081
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Primary Completion: 2009-09
• Study Completion: 2010-01
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-28
• Last Update Posted: 2010-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ciclosporine A	-
1	Prednisolone	-

Primary Outcome Measures

Name	Time	Method
stable remission in both treatment groups

Secondary Outcome Measures

Name	Time	Method
change in presenteeism in both treatment groups
patient satisfaction
change in disease symptoms (POEM)in both treatment groups
Cost-effectiveness of both treatments
Tolerability and Safety
mean change in objective SCORAD in both treatment groups
mean change in HRQL (DLQI) in both treatment groups
response rate in both treatment groups
relapse rate in both treatment groups

Trial Locations

Locations (5)

Dept. of Dermatology, Medical Faculty, TU Dresden; 🇩🇪 Dresden, Germany

University Hospital of Dermatology and Venerology Graz; 🇦🇹 Graz, Austria

Dpt. of Dermatology, Medical Faculty Eppendorf; 🇩🇪 Hamburg, Germany

Dpt. of Dermatology, University Hospital Münster; 🇩🇪 Münster, Germany

University Hospital Kiel; 🇩🇪 Kiel, Germany