Psoriasis VulgarisPhase 2VITAKETNCT00678756
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
A Phase 2 study testing Ketokonazol 2% cream and UVB-radiation 311nm in people with Psoriasis Vulgaris, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Ketokonazol 2% cream and UVB-radiation 311nm
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18- 80
- diagnosis of psoriasis vulgaris (mild- middle)
- no other current antipsoriatic therapy (systemic/topical)
- at least 5 psoriatic areas of 5x5 cm
Who cannot join
- pregnancy/nursing mothers
- women in reproductive age without adequate contraception
- severe and acute forms of psoriasis vulgaris
- patients receiving systemic or topical antipsoroatic treatment in past 3 month
- UV-therapy in past 3 month
- patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma
- epilepsy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Medical Faculty, TU Dresden
Dresden, 01307
About this study
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin
- Conditions
- Psoriasis Vulgaris
- Being tested
- Ketokonazol 2% cream, UVB-radiation 311nm
- Keywords
- Psoriasis vulgaris,, vitamin D, UVB-phototherapy, ketokonazol,, Optical Coherence Tomography,, local PASI, Nizoral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketokonazol 2% creamDrug
Also called Nizoral cream
twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week
UVB-radiation 311nmRadiation
Also called UVB Radiation, phototherapy, narrow-band ultraviolet B phototherapy
3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI, PGA
Measured: 4 weeks
Secondary outcomes (1)
OCT/ultrasound- thickness of epidermis/ dermis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Gottfried Wozel, Prof. Dr.med, Principal investigator, Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678756
- Sponsor's protocol ID
- TUD-VITAKET
- Acronym
- VITAKET
- Status last verified
- Jun 2010
- First submitted
- 14 May 2008
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
- Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
- ClinicalTrials.gov ID
- NCT00678756
- Acronym / sponsor ID
- VITAKET / TUD-VITAKET
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis vulgaris,, vitamin D, UVB-phototherapy, ketokonazol,, Optical Coherence Tomography,, local PASI, Nizoral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 May 2008 (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.
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: 18- 80
- diagnosis of psoriasis vulgaris (mild- middle)
- no other current antipsoriatic therapy (systemic/topical)
- at least 5 psoriatic areas of 5x5 cm
Key exclusion criteria (7 listed)
- pregnancy/nursing mothers
- women in reproductive age without adequate contraception
- severe and acute forms of psoriasis vulgaris
- patients receiving systemic or topical antipsoroatic treatment in past 3 month
- UV-therapy in past 3 month
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 |
|---|---|---|
| Ketokonazol 2% creamAlso: Nizoral creamtwice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week | Drug | – |
| UVB-radiation 311nmAlso: UVB Radiation, phototherapy, narrow-band ultraviolet B phototherapy3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm | Radiation | – |
Primary outcome
PASI, PGA
Time frame: 4 weeks
1 secondary outcome
OCT/ultrasound- thickness of epidermis/ dermis
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
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, Prof. Dr.med principal investigator
Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketokonazol 2% cream and UVB-radiation 311nm 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 7 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: status not confirmed, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
PASI, PGA (time frame: 4 weeks). 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.