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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
  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
Intervention Model: Single Group Assignment
Masking: None (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 Nicolas Hunzelmann, University of Cologne:

Primary Outcome Measures:
  • modified skin score [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • modified skin score [ Time Frame: 6 months ]
  • histologic examination [ Time Frame: 3 months ]

Enrollment: 9
Study Start Date: February 2008
Study Completion Date: November 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628797


Locations
Germany
University of Tuebingen, Dept. of Dermatology
Tuebingen, BW, Germany, 72076
University of Cologne, Dept. of Dermatology
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
Nicolas Hunzelmann
University Hospital Tuebingen
Investigators
Principal Investigator: Nicolas Hunzelmann University of Cologne, Dept. of Dermatology
  More Information

Responsible Party: Nicolas Hunzelmann, Prof. Dr. N. Hunzelmann, University of Cologne
ClinicalTrials.gov Identifier: NCT00628797     History of Changes
Other Study ID Numbers: 07-200
First Submitted: February 26, 2008
First Posted: March 5, 2008
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Nicolas Hunzelmann, University of Cologne:
systemic sclerosis
skin fibrosis

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