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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)

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ClinicalTrials.gov Identifier: NCT00678756
Recruitment Status : Unknown
Verified June 2010 by Technische Universität Dresden.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2008
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. PASI, PGA [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. OCT/ultrasound- thickness of epidermis/ dermis [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: June 2010

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
Ketoconazole
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors