Status unknownNCT00678756VITAKETUpdated Jun 8, 2010

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 interventional study of Ketokonazol 2% cream and UVB-radiation 311nm in Psoriasis Vulgaris, sponsored by Technische Universität Dresden. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-06-08.

Sponsored by Technische Universität Dresden · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Non-randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin

Conditions studied

Psoriasis Vulgaris

Keywords

Psoriasis vulgaris,
vitamin D, UVB-phototherapy, ketokonazol,
Optical Coherence Tomography,
local PASI, Nizoral

In context

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

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Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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Inclusion criteria

age: 18- 80
diagnosis of psoriasis vulgaris (mild- middle)
no other current antipsoriatic therapy (systemic/topical)
at least 5 psoriatic areas of 5x5 cm

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 12 participants (estimated)

Interventions

DrugKetokonazol 2% cream
twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week
Also known as: Nizoral cream
RadiationUVB-radiation 311nm
3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm
Also known as: UVB Radiation, phototherapy, narrow-band ultraviolet B phototherapy

What researchers measure

Primary outcomes

PASI, PGA
Time frame: 4 weeks

Secondary outcomes

OCT/ultrasound- thickness of epidermis/ dermis
Time frame: 4 weeks

Study locations

1 site

Department of Dermatology, Medical Faculty, TU Dresden
Dresden, 01307, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00678756
Lead sponsor: Technische Universität Dresden
First posted: May 16, 2008
Start date: Mar 2008
Primary completion: Oct 2009 (estimated)
Completion: Dec 2009 (estimated)
Last update: Jun 8, 2010

Study contacts

Gottfried Wozel, Prof. Dr.med

principal investigator · Department of Dermatology, Medical Faculty, Technical University Dresden, Germany

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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