Effectiveness of UVA1-Irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis

This study is currently recruiting participants.

Verified by University of Cologne, February 2008

Sponsors and Collaborators:	University of Cologne University Hospital Tuebingen
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00628797

Purpose

Systemic scleroderma (SSc) is a rare chronic inflammatory diseae of the connective tissue involving the skin and internal organs. To date there is no proven therapy for the skin fibrosis available. A number of case reports and small uncontrolled cohort studies suggest that UVA1 therapy may improve skin fibrosis. The aim of this study is therefore to investigate whether treatment UVA1 in deed is effective in treating skin fibrosis in SSc using a randomized, intraindividual half body irradiation protocol.

Condition	Intervention	Phase
Systemic Scleroderma Systemic Sclerosis	Radiation: UVA1	Phase I Phase II

MedlinePlus related topics: Scleroderma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie

Further study details as provided by University of Cologne:

Primary Outcome Measures:

modified skin score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

modified skin score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
histologic examination [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A intervention B no intervention half body irradiation	Radiation: UVA1 intraindividual half body irradiation

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

systemic sclerosis ACR criteria
skin fibrosis at least involving the distal third of the lower arm

Exclusion Criteria:

photosensitizing drugs
recent UV therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628797

Contacts

Contact: Nicolas Hunzelmann, MD	0221-478 ext 5086	nico.hunzelmann@uni-koeln.de
Contact: Mark Berneburg, MD	o7o71-298 ext 0869	mark.berneburg@med.uni-tuebingen.de

Locations

Germany, BW
University of Tuebingen, Dept. of Dermatology	Recruiting
Tuebingen, BW, Germany, 72076
Contact: Mark Berneburg, MD 07071-298 ext 0869 mark.berneburg@med.uni-tuebingen.de
Principal Investigator: Mark Berneburg, MD
Germany, NRW
University of Cologne, Dept. of Dermatology	Recruiting
Cologne, NRW, Germany, 50937
Contact: Nicolas Hunzelmann, MD 0221-478- ext 5086 nico.hunzelmann@uni-koeln.de
Principal Investigator: Nicolas Hunzelmann, MD

Sponsors and Collaborators

University of Cologne

University Hospital Tuebingen

Investigators

Principal Investigator:

Nicolas Hunzelmann

University of Cologne, Dept. of Dermatology

More Information

Responsible Party:	University of Cologne ( Prof. Dr. N.Hunzelmann )
Study ID Numbers:	07-200
Study First Received:	February 26, 2008
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00628797
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

systemic sclerosis
skin fibrosis

Study placed in the following topic categories:

Skin Diseases
Fibrosis
Connective Tissue Diseases
Sclerosis
Scleroderma, Systemic

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009