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”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: Ketokonazol 2% cream
  • twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week
• Radiation: UVB-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

Primary Measures

• PASI, PGA
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• OCT/ultrasound- thickness of epidermis/ dermis
  • Time Frame: 4 weeks
    Safety Issue?: No

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:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

Gottfried Wozel, Prof. Dr.med Principal Investigator Department of Dermatology, Medical Faculty, Technical University Dresden, Germany  

Overall Contact: Gottfried Wozel, Prof. Dr. med 0049-351-458 katharina.bluemlein@mailbox.tu-dresden.de

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00678756

Study ID Number: TUD-VITAKET

ClinicalTrials.gov Identifier: NCT00678756

Health Authority: Germany: Federal Institute for Drugs and Medical Devices