NCT00678756

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

1.6 years

First QC Date

May 14, 2008

Last Update Submit

June 7, 2010

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis vulgaris,vitamin D, UVB-phototherapy, ketokonazol,Optical Coherence Tomography,local PASI, Nizoral

Outcome Measures

Primary Outcomes (1)

  • PASI, PGA

    4 weeks

Secondary Outcomes (1)

  • OCT/ultrasound- thickness of epidermis/ dermis

    4 weeks

Interventions

Ketokonazol 2% creamDRUG

twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week

Also known as: Nizoral cream
UVB-radiation 311nmRADIATION

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

Also known as: UVB Radiation, phototherapy, narrow-band ultraviolet B phototherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 18- 80
  • diagnosis of psoriasis vulgaris (mild- middle)
  • no other current antipsoriatic therapy (systemic/topical)
  • at least 5 psoriatic areas of 5x5 cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Medical Faculty, TU Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gottfried Wozel, Prof. Dr.med

    Department of Dermatology, Medical Faculty, Technical University Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

June 8, 2010

Record last verified: 2010-06

Locations

DE(1)