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
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis Vulgaris
Intervention: Ketokonazol 2% cream (Drug); UVB-radiation 311nm (Radiation)
Phase: Phase 2
Status: Recruiting
Sponsored by: Dresden University of Technology Official(s) and/or principal investigator(s):
Gottfried Wozel, Prof. Dr.med, Principal Investigator, Affiliation: Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Overall contact:
Gottfried Wozel, Prof. Dr. med, Phone: 0049-351-458, Email: katharina.bluemlein@mailbox.tu-dresden.de
Summary
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on
affected psoriatic skin
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: PASI, PGA
Secondary outcome: OCT/ultrasound- thickness of epidermis/ dermis
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Gottfried Wozel, Prof. Dr. med, Phone: 0049-351-458, Email: katharina.bluemlein@mailbox.tu-dresden.de
Department of Dermatology, Medical Faculty, TU Dresden, Dresden 01307, Germany; Recruiting
Gottfried Wozel, Prof. Dr.med., Phone: 0049-351-458, Ext: 2007, Email: katharina.bluemlein@mailbox.tu-dresden.de
Gottfried Wozel, Prof. Dr.med, Principal Investigator
Sophia Deter, cand.med., Sub-Investigator
Additional Information
Starting date: March 2008
Ending date: December 2009
Last updated: May 14, 2008
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