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

Verified by: Dresden University of Technology, June 2010
First Received: May 14, 2008 | Last Updated: June 7, 2010 | Phase: Phase 2 | Start Date: March 2008
Overall Status: Active, not recruiting | Estimated Enrollment: 12
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Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic...

Brief Summary

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: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Dresden University of Technology Other

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00678756