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Prednisolone vs. Ciclosporine in Severe Atopic Eczema (PROVE)
This study is currently recruiting participants.
Verified by Dresden University of Technology, July 2008
Sponsored by: Dresden University of Technology
Information provided by: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00445081
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
 Drug: Prednisolone
Drug: Ciclosporine A
 Phase IV

MedlinePlus related topics: Eczema
Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title: Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • stable remission in both treatment groups

Secondary Outcome Measures:
  • 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
  • patient satisfaction

Estimated Enrollment: 66
Study Start Date: March 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Prednisolone
2: Active Comparator Drug: Ciclosporine A

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445081

Contacts
Contact: Jochen M Schmitt, MD, MPH 0049 351 458 ext 2421 Jochen.Schmitt@uniklinikum-dresden.de
Contact: Michael Meurer, Prof., MD 0049 351 458 ext 2497

Locations
Austria
University Hospital of Dermatology and Venerology Graz Recruiting
Graz, Austria, 8036
Contact: Werner Aberer, Prof., MD            
Principal Investigator: Werner Aberer, Prof., MD            
Sub-Investigator: Christian Schuster, MD            
Germany
Dept. of Dermatology, Medical Faculty, TU Dresden Recruiting
Dresden, Germany, 01307
Contact: Jochen M Schmitt, MD MPH     00493514582421     jochen.schmitt@uniklinikum-dresden.de    
Principal Investigator: Jochen M Schmitt, MD MPH            
Sub-Investigator: Marlene Lochno            
Sub-Investigator: Knut Schäkel, PD, MD            
University Hospital Kiel Recruiting
Kiel, Germany, 24105
Contact: Regina Fölster-Holst, PD, MD     0049 431 5971512        
Principal Investigator: Regina Fölster-Holst, PD, MD            
Sub-Investigator: Shirin Filsoof            
Sub-Investigator: Konstanze Müller-Wening            
Dpt. of Dermatology, Medical Faculty Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Matthias Augustin, Prof., MD            
Principal Investigator: Matthias Augustin, Prof., MD            
Sub-Investigator: Nadine Franzke            
Dpt. of Dermatology, University Hospital Münster Recruiting
Münster, Germany, 48149
Contact: Thomas Luger, Prof., MD            
Principal Investigator: Thomas Luger, Prof., MD            
Sub-Investigator: Mareike Eickelmann            
Sub-Investigator: Sarah Schulz            
Sub-Investigator: Funda Schürmeyer-Horst, MD            
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Jochen M Schmitt, MD MPH Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
  More Information

Responsible Party: Technical University Dresden ( Jochen Schmitt, MD, MPH )
Study ID Numbers: TUD_PROVE_001, EudraCT-Nr:2006-003667-31
Study First Received: March 7, 2007
Last Updated: July 7, 2008
ClinicalTrials.gov Identifier: NCT00445081  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
atopic dermatitis
prednisolone
ciclosporine
SCORAD
 DLQI
QALY
WLQ

Study placed in the following topic categories:
Dermatitis, Atopic
Skin Diseases
Methylprednisolone
Methylprednisolone acetate
Prednisolone acetate
Eczema
Hypersensitivity
 Genetic Diseases, Inborn
Prednisolone
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protective Agents
 Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009



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