- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00678756
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)
June 7, 2010 updated by: Technische Universität Dresden
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dresden, Germany, 01307
- Department of Dermatology, Medical Faculty, TU Dresden
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PASI, PGA
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
OCT/ultrasound- thickness of epidermis/ dermis
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gottfried Wozel, Prof. Dr.med, Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Anticipated)
October 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
May 14, 2008
First Submitted That Met QC Criteria
May 14, 2008
First Posted (Estimate)
May 16, 2008
Study Record Updates
Last Update Posted (Estimate)
June 8, 2010
Last Update Submitted That Met QC Criteria
June 7, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Ketoconazole
Other Study ID Numbers
- TUD-VITAKET
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis Vulgaris
-
LEO PharmaCompletedPlaque Psoriasis | Psoriasis VulgarisGermany
-
SoligenixRecruitingPsoriasis | Plaque Psoriasis | Psoriasis VulgarisUnited States
-
LEO PharmaTerminatedPsoriasis | Plaque Psoriasis | Psoriasis VulgarisBelgium, Germany, Italy, Spain, Denmark, Austria, France, Greece, Switzerland, United Kingdom, Netherlands, Sweden
-
PRCL Research Inc.CompletedPlaque Psoriasis | Psoriasis VulgarisCanada, Slovakia, Ukraine
-
University Hospital, GhentBelgium Health Care Knowledge CentreNot yet recruiting
-
Chinese University of Hong KongNot yet recruitingPsoriasis Vulgaris
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRecruitingPsoriasis VulgarisUnited States
-
Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsRecruiting
Clinical Trials on Ketokonazol 2% cream
-
UNION therapeuticsCompletedAtopic DermatitisCanada
-
LEO PharmaCompletedImpetigo | Secondarily Infected Traumatic Lesions (SITL)United States
-
Betta Pharmaceuticals Co., Ltd.Quintiles, Inc.Completed
-
University of ParmaCompletedInflammatory Response | Endotoxemia | Oxidative Stress | Glucose, High BloodItaly
-
Taro Pharmaceuticals USACompleted
-
Jamaica Hospital Medical CenterJohnson & JohnsonUnknownTinea Pedis | Athlete's Foot | Foot Fungus | RingwormUnited States
-
GlaxoSmithKlineCompleted
-
LUTRONIC CorporationCompleted
-
Chulalongkorn UniversityNot yet recruiting
-
Merz North America, Inc.CompletedTinea CorporisUnited States, Dominican Republic, Honduras