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 (VITAKET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Technische Universität Dresden.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00678756
First received: May 14, 2008
Last updated: June 7, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
Drug: Ketokonazol 2% cream
Radiation: UVB-radiation 311nm
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • PASI, PGA [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OCT/ultrasound- thickness of epidermis/ dermis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: Nizoral cream
    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
    Other Name: UVB Radiation, phototherapy, narrow-band ultraviolet B phototherapy
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678756

Locations
Germany
Department of Dermatology, Medical Faculty, TU Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Gottfried Wozel, Prof. Dr.med Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Gottfried Wozel, Technical University Dresden, Department of Dermatology
ClinicalTrials.gov Identifier: NCT00678756     History of Changes
Other Study ID Numbers: TUD-VITAKET
Study First Received: May 14, 2008
Last Updated: June 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Psoriasis vulgaris,
vitamin D, UVB-phototherapy, ketokonazol,
Optical Coherence Tomography,
local PASI, Nizoral

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Dihydroxycholecalciferols
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014