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Prednisolone vs. Ciclosporine in Severe Atopic Eczema (PROVE)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Prednisolone
Ciclosporine A
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, prednisolone, ciclosporine, SCORAD, DLQI, QALY, WLQ

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Dermatology and Venerology Graz
  • Dept. of Dermatology, Medical Faculty, TU Dresden
  • Dpt. of Dermatology, Medical Faculty Eppendorf
  • University Hospital Kiel
  • Dpt. of Dermatology, University Hospital Münster

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

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

Full Information

First Posted
March 7, 2007
Last Updated
October 28, 2010
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00445081
Brief Title
Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Acronym
PROVE
Official Title
Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, prednisolone, ciclosporine, SCORAD, DLQI, QALY, WLQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Type
Drug
Intervention Name(s)
Ciclosporine A
Primary Outcome Measure Information:
Title
stable remission in both treatment groups
Secondary Outcome Measure Information:
Title
response rate in both treatment groups
Title
relapse rate in both treatment groups
Title
mean change in objective SCORAD in both treatment groups
Title
mean change in HRQL (DLQI) in both treatment groups
Title
change in disease symptoms (POEM)in both treatment groups
Title
Cost-effectiveness of both treatments
Title
Tolerability and Safety
Title
change in presenteeism in both treatment groups
Title
patient satisfaction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen M Schmitt, MD MPH
Organizational Affiliation
Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Dermatology and Venerology Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Dept. of Dermatology, Medical Faculty, TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Dpt. of Dermatology, Medical Faculty Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University Hospital Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Dpt. of Dermatology, University Hospital Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19863501
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.
Results Reference
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Prednisolone vs. Ciclosporine in Severe Atopic Eczema

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