Prednisolone vs. Ciclosporine in Severe Atopic Eczema (PROVE)

October 28, 2010 updated by: Technische Universität Dresden
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • University Hospital of Dermatology and Venerology Graz
  • Germany
      • Dresden, Germany, 01307
        • Dept. of Dermatology, Medical Faculty, TU Dresden
      • Hamburg, Germany, 20246
        • Dpt. of Dermatology, Medical Faculty Eppendorf
      • Kiel, Germany, 24105
        • University Hospital Kiel
      • Münster, Germany, 48149
        • Dpt. of Dermatology, University Hospital Münster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: Ciclosporine A
Active Comparator: 1
Drug: Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
stable remission in both treatment groups

Secondary Outcome Measures

Outcome Measure
patient satisfaction
response rate in both treatment groups
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
Cost-effectiveness of both treatments
Tolerability and Safety
change in presenteeism in both treatment groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Jochen M Schmitt, MD MPH, Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD_PROVE_001
  • EudraCT-Nr:2006-003667-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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