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Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Information source: Technische Universitšt Dresden
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atopic Dermatitis

Intervention: Prednisolone (Drug); Ciclosporine A (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Technische Universitšt Dresden

Official(s) and/or principal investigator(s):
Jochen M Schmitt, MD MPH, Principal Investigator, Affiliation: Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden

Summary

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

Clinical Details

Official title: Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: stable remission in both treatment groups

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

University Hospital of Dermatology and Venerology Graz, Graz 8036, Austria

Dept. of Dermatology, Medical Faculty, TU Dresden, Dresden 01307, Germany

Dpt. of Dermatology, Medical Faculty Eppendorf, Hamburg 20246, Germany

University Hospital Kiel, Kiel 24105, Germany

Dpt. of Dermatology, University Hospital M√ľnster, M√ľnster 48149, Germany

Additional Information

Starting date: March 2007
Last updated: October 28, 2010

Page last updated: August 23, 2015

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