NCT00445081

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

2.5 years

First QC Date

March 7, 2007

Last Update Submit

October 28, 2010

Conditions

Atopic Dermatitis

Keywords

atopic dermatitisprednisoloneciclosporineSCORADDLQIQALYWLQ

Outcome Measures

Primary Outcomes (1)

  • stable remission in both treatment groups

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Prednisolone

2

ACTIVE COMPARATOR
Drug: Ciclosporine A

Interventions

PrednisoloneDRUG
1
Ciclosporine ADRUG
2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital of Dermatology and Venerology Graz

Graz, 8036, Austria

Location

Dept. of Dermatology, Medical Faculty, TU Dresden

Dresden, 01307, Germany

Location

Dpt. of Dermatology, Medical Faculty Eppendorf

Hamburg, 20246, Germany

Location

University Hospital Kiel

Kiel, 24105, Germany

Location

Dpt. of Dermatology, University Hospital Münster

Münster, 48149, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19863501DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jochen M Schmitt, MD MPH

    Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

March 1, 2007

Primary Completion

September 1, 2009

Study Completion

January 1, 2010

Last Updated

October 29, 2010

Record last verified: 2010-10

Locations

AU(1)DE(4)