VITAKET: 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

Sponsor

Technische Universität Dresden (Other)

Overall Status

Unknown status

CT.gov ID

NCT00678756

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Mar 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

PASI, PGA [4 weeks]

Secondary Outcome Measures

OCT/ultrasound- thickness of epidermis/ dermis [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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