Prednisolone vs. Ciclosporine in Severe Atopic Eczema (PROVE)

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00445081
First received: March 7, 2007
Last updated: October 28, 2010
Last verified: October 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

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
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Prednisolone
Active Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445081

Locations
Austria
University Hospital of Dermatology and Venerology Graz
Graz, Austria, 8036
Germany
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
Investigators
Principal Investigator: Jochen M Schmitt, MD MPH Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
  More Information

No publications provided by Technische Universität Dresden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen Schmitt, MD, MPH, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00445081     History of Changes
Other Study ID Numbers: TUD_PROVE_001, EudraCT-Nr:2006-003667-31
Study First Received: March 7, 2007
Last Updated: October 28, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
atopic dermatitis
prednisolone
ciclosporine
SCORAD
DLQI
QALY
WLQ

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014