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 currently recruiting participants.

Verified by Dresden University of Technology, May 2008

First Received: May 14, 2008 No Changes Posted

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:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcitriol 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

3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm

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

Contacts

Contact: Gottfried Wozel, Prof. Dr. med

0049-351-458

katharina.bluemlein@mailbox.tu-dresden.de

Locations

Germany
Department of Dermatology, Medical Faculty, TU Dresden	Recruiting
Dresden, Germany, 01307
Contact: Gottfried Wozel, Prof. Dr.med. 0049-351-458 ext 2007 katharina.bluemlein@mailbox.tu-dresden.de
Principal Investigator: Gottfried Wozel, Prof. Dr.med
Sub-Investigator: Sophia Deter, cand.med.

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:	Technical University Dresden, Department of Dermatology ( Prof. Dr. med. Gottfried Wozel )
Study ID Numbers:	TUD-VITAKET
Study First Received:	May 14, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00678756 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Bone Density Conservation Agents
Cardiovascular Agents
Dihydroxycholecalciferols
Pharmacologic Actions

Calcitriol
Membrane Transport Modulators
Psoriasis
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 09, 2010