Clinical trial NCT00445081: Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Official title: Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
prednisolone
ciclosporine
SCORAD
DLQI
QALY
WLQ
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: stable remission in both treatment groups
Secondary outcomes:
measure: response rate in both treatment groups
measure: relapse rate in both treatment groups
measure: mean change in objective SCORAD in both treatment groups
measure: mean change in HRQL (DLQI) in both treatment groups
measure: change in disease symptoms (POEM)in both treatment groups
measure: Cost-effectiveness of both treatments
measure: Tolerability and Safety
measure: change in presenteeism in both treatment groups
measure: patient satisfaction
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Hospital of Dermatology and Venerology Graz
city: Dresden
country: Germany
facility: Dept. of Dermatology, Medical Faculty, TU Dresden
city: Hamburg
country: Germany
facility: Dpt. of Dermatology, Medical Faculty Eppendorf
city: Kiel
country: Germany
facility: University Hospital Kiel
city: Münster
country: Germany
facility: Dpt. of Dermatology, University Hospital Münster
Study officials:
affiliation: Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
name: Jochen M Schmitt, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitt J, Schakel K, Folster-Holst R, Bauer A, Oertel R, Augustin M, Aberer W, Luger T, Meurer M. Prednisolone vs. ciclosporin for severe adult eczema. An investigator-initiated double-blind placebo-controlled multicentre trial. Br J Dermatol. 2010 Mar;162(3):661-8. doi: 10.1111/j.1365-2133.2009.09561.x. Epub 2009 Oct 26.