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 - Full Text View

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)

This study is ongoing, but not recruiting participants.

First Received on May 14, 2008. Last Updated on June 7, 2010 History of Changes

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00678756

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 II

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:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcitriol Ketoconazole Fungarest

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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:

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

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

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

Dresden University of Technology

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 Dresden University of Technology:

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
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012