Atopic DermatitisPhase 4PROVENCT00445081
Prednisolone vs. Ciclosporine in Severe Atopic Eczema
A Phase 4 study testing Prednisolone and Ciclosporine A in people with Atopic Dermatitis, run by Technische Universität Dresden at 5 sites in 2 countries.
Trial summary
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Prednisolone and Ciclosporine A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Mar 2007to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Dept. of Dermatology, Medical Faculty, TU Dresden
Dresden, 01307
Dpt. of Dermatology, Medical Faculty Eppendorf
Hamburg, 20246
University Hospital Kiel
Kiel, 24105
Dpt. of Dermatology, University Hospital Münster
Münster, 48149
Austria1 site
University Hospital of Dermatology and Venerology Graz
Graz, 8036
About this study
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Prednisolone, Ciclosporine A
- Keywords
- atopic dermatitis, prednisolone, ciclosporine, SCORAD, DLQI, QALY, WLQ
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Ciclosporine ADrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Prednisolone |
| 2 | Active comparator | Not described Receives: Drug: Ciclosporine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Cost-effectiveness of both treatments
Tolerability and Safety
change in presenteeism in both treatment groups
patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Jochen M Schmitt, MD MPH, Principal investigator, Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445081
- Sponsor's protocol ID
- TUD_PROVE_001
- Other IDs
- EudraCT-Nr:2006-003667-31
- Acronym
- PROVE
- Status last verified
- Oct 2010
- First submitted
- 7 Mar 2007
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19863501
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisolone vs. Ciclosporine in Severe Atopic Eczema
- ClinicalTrials.gov ID
- NCT00445081
- Acronym / sponsor ID
- PROVE / TUD_PROVE_001
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, prednisolone, ciclosporine, SCORAD, DLQI, QALY, WLQ
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Prednisolone |
| 2 | Active comparator | Drug: Ciclosporine A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolone | Drug | 1 |
| Ciclosporine A | Drug | 2 |
Primary outcome
stable remission in both treatment groups
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
- Derived from this study: PubMed 19863501Schmitt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen M Schmitt, MD MPH principal investigator
Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone and Ciclosporine A in people with Atopic Dermatitis, run by Technische Universität Dresden at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stable remission in both treatment groups. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00445081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2010.