Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Atopic Dermatitis Clinical Trial

— PROVE  

Official title:

Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445081
• Other study ID #: TUD_PROVE_001
• Secondary ID: EudraCT-Nr:2006-
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2007
• Last updated: October 28, 2010
• Start date: March 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2010
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Prednisolone

• Ciclosporine A

Locations

Country	Name	City	State
Austria	University Hospital of Dermatology and Venerology Graz	Graz
Germany	Dept. of Dermatology, Medical Faculty, TU Dresden	Dresden
Germany	Dpt. of Dermatology, Medical Faculty Eppendorf	Hamburg
Germany	University Hospital Kiel	Kiel
Germany	Dpt. of Dermatology, University Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stable remission in both treatment groups
Secondary	response rate in both treatment groups
Secondary	relapse rate in both treatment groups
Secondary	mean change in objective SCORAD in both treatment groups
Secondary	mean change in HRQL (DLQI) in both treatment groups
Secondary	change in disease symptoms (POEM)in both treatment groups
Secondary	Cost-effectiveness of both treatments
Secondary	Tolerability and Safety
Secondary	change in presenteeism in both treatment groups
Secondary	patient satisfaction