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

Psoriasis Vulgaris Clinical Trial

— VITAKET  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00678756
• Other study ID #: TUD-VITAKET
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: June 7, 2010
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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

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

Locations

Country	Name	City	State
Germany	Department of Dermatology, Medical Faculty, TU Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI, PGA		4 weeks	No
Secondary	OCT/ultrasound- thickness of epidermis/ dermis		4 weeks	No