Psoriasis VulgarisNCT00236171
Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test
A study testing Protopic, Advantan, Blood and Urine Test and coherence tomography in people with Psoriasis Vulgaris, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy of the topical therapies Protopic and Advantan as well as their combination against placebo in a Psoriasis Plaque Test Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Protopic, Advantan, Blood and Urine Test and coherence tomography
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to Jun 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 Years
- Negative urine pregnancy test
- Written informed consent
- Good compliance
Who cannot join
- Patients less than 18 years
- Pregnant patients
- Patients with renal insufficiency, liver diseases
- Patients who received systemic antipsoriatic treatment or UV treatment less than 4 weeks prior to study
- Patients who used topical antipsoriatics within two weeks prior to study
- Immunosuppressed Patients
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of the topical therapies Protopic and Advantan as well as their combination against placebo in a Psoriasis Plaque Test
Read the detailed description
daily psoriasis plaque tests for two weeks and optical coherence tomography (OCT) and 20-MHz-ultrasound on day 0 and day 11, 10 days post end of treatment and 20 days post end of treatment
- Conditions
- Psoriasis Vulgaris
- Being tested
- Protopic, Advantan, Blood and Urine Test, coherence tomography
- Keywords
- topical therapy, Psoriasis Plaque Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protopic, AdvantanDrug
Blood and Urine TestProcedure or surgery
coherence tomographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
sum score of psoriasis plaque tests on day 11
Secondary outcomes (1)
20-MHz-ultrasound and OCT on day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startSep 2004
- Primary completionApr 2006
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Gottfried Wozel, Professor, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236171
- Sponsor's protocol ID
- ETAPSO
- Status last verified
- Jun 2010
- First submitted
- 4 Oct 2005
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test
- ClinicalTrials.gov ID
- NCT00236171
- Acronym / sponsor ID
- ETAPSO
- Conditions
- Psoriasis Vulgaris
- Keywords
- topical therapy, Psoriasis Plaque Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Oct 2005 (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.
The purpose of this study is to evaluate the efficacy of the topical therapies Protopic and Advantan as well as their combination against placebo in a Psoriasis Plaque Test
Detailed description
daily psoriasis plaque tests for two weeks and optical coherence tomography (OCT) and 20-MHz-ultrasound on day 0 and day 11, 10 days post end of treatment and 20 days post end of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 Years
- Negative urine pregnancy test
- Written informed consent
- Good compliance
Key exclusion criteria (6 listed)
- Patients less than 18 years
- Pregnant patients
- Patients with renal insufficiency, liver diseases
- Patients who received systemic antipsoriatic treatment or UV treatment less than 4 weeks prior to study
- Patients who used topical antipsoriatics within two weeks prior to study
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 |
|---|---|---|
| Protopic, Advantan | Drug | – |
| Blood and Urine Test | Procedure or surgery | – |
| coherence tomography | Procedure or surgery | – |
Primary outcome
sum score of psoriasis plaque tests on day 11
1 secondary outcome
20-MHz-ultrasound and OCT on day 11
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 8 Jun 2010.
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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.
Gottfried Wozel, Professor principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protopic, Advantan, Blood and Urine Test and coherence tomography in people with Psoriasis Vulgaris, run by Technische Universität Dresden at 1 site in Germany.
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 4 inclusion and 6 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 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
sum score of psoriasis plaque tests on day 11. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2010.