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Prednisolone vs. Ciclosporine in Severe Atopic Eczema (PROVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445081
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : October 29, 2010
Information provided by:
Technische Universität Dresden

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Prednisolone Drug: Ciclosporine A Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Study Start Date : March 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Active Comparator: 1 Drug: Prednisolone
Active Comparator: 2 Drug: Ciclosporine A

Primary Outcome Measures :
  1. stable remission in both treatment groups

Secondary Outcome Measures :
  1. response rate in both treatment groups
  2. relapse rate in both treatment groups
  3. mean change in objective SCORAD in both treatment groups
  4. mean change in HRQL (DLQI) in both treatment groups
  5. change in disease symptoms (POEM)in both treatment groups
  6. Cost-effectiveness of both treatments
  7. Tolerability and Safety
  8. change in presenteeism in both treatment groups
  9. patient satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445081

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University Hospital of Dermatology and Venerology Graz
Graz, Austria, 8036
Dept. of Dermatology, Medical Faculty, TU Dresden
Dresden, Germany, 01307
Dpt. of Dermatology, Medical Faculty Eppendorf
Hamburg, Germany, 20246
University Hospital Kiel
Kiel, Germany, 24105
Dpt. of Dermatology, University Hospital Münster
Münster, Germany, 48149
Sponsors and Collaborators
Technische Universität Dresden
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Principal Investigator: Jochen M Schmitt, MD MPH Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jochen Schmitt, MD, MPH, Technical University Dresden Identifier: NCT00445081    
Other Study ID Numbers: TUD_PROVE_001
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: October 29, 2010
Last Verified: October 2010
Keywords provided by Technische Universität Dresden:
atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors