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Completed

NCT Number: NCT00445081

Prednisolone vs. Ciclosporine in Severe Atopic Eczema

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Dermatology and Venerology Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

Ciclosporine A

Drug

Primary outcomes

  1. stable remission in both treatment groups

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Acronym: PROVE

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 8, 2007
Registry last updated
Oct 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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