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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00628797
First received: February 26, 2008
Last updated: January 27, 2010
Last verified: January 2010
  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
Other: UVA1
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie

Resource links provided by NLM:


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 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A UVA1 B no UVA1
half body irradiation with random allocation right and left; after three months of treatment treatment of both sides
Other: UVA1
60 J/cm2 at least 36 tx
Other Name: Ultraviolet light
Experimental: A UVA1 Radiation: UVA1
intraindividual half body irradiation
Other Name: ultraviolet light
Other: UVA1
60 J/cm2 at least 36 tx
Other Name: Ultraviolet light

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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         
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

No publications provided

Responsible Party: Prof. Dr. N.Hunzelmann, University of Cologne
ClinicalTrials.gov Identifier: NCT00628797     History of Changes
Other Study ID Numbers: 07-200
Study First Received: February 26, 2008
Last Updated: January 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
systemic sclerosis
skin fibrosis

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Systemic
Sclerosis
Connective Tissue Diseases
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014