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

This study has been terminated.
(lack of recruitement)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00628797
First Posted: March 5, 2008
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
Nicolas Hunzelmann, University of Cologne
February 26, 2008
March 5, 2008
May 31, 2017
February 2008
July 2010   (Final data collection date for primary outcome measure)
modified skin score [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00628797 on ClinicalTrials.gov Archive Site
  • modified skin score [ Time Frame: 6 months ]
  • histologic examination [ Time Frame: 3 months ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Terminated
9
November 2013
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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00628797
07-200
No
Not Provided
Not Provided
Nicolas Hunzelmann, University of Cologne
Nicolas Hunzelmann
University Hospital Tuebingen
Principal Investigator: Nicolas Hunzelmann University of Cologne, Dept. of Dermatology
University of Cologne
May 2017

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