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

February 26, 2008
January 27, 2010
February 2008
July 2010   (final data collection date for primary outcome measure)
modified skin score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00628797 on ClinicalTrials.gov Archive Site
  • modified skin score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • histologic examination [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of UVA1-irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis
Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Systemic Scleroderma
  • Systemic Sclerosis
  • Radiation: UVA1
    intraindividual half body irradiation
    Other Name: ultraviolet light
  • Other: UVA1
    60 J/cm2 at least 36 tx
    Other Name: Ultraviolet light
  • A UVA1 B no UVA1
    half body irradiation with random allocation right and left; after three months of treatment treatment of both sides
    Intervention: Other: UVA1
  • Experimental: A UVA1
    Interventions:
    • Radiation: UVA1
    • Other: UVA1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
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
Germany
 
NCT00628797
07-200
No
Prof. Dr. N.Hunzelmann, University of Cologne
University of Cologne
University Hospital Tuebingen
Principal Investigator: Nicolas Hunzelmann University of Cologne, Dept. of Dermatology
University of Cologne
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP