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

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. Identifier: NCT00628797
Recruitment Status : Terminated (lack of recruitement)
First Posted : March 5, 2008
Last Update Posted : May 31, 2017
University Hospital Tuebingen
Information provided by (Responsible Party):
Nicolas Hunzelmann, University of Cologne

Brief Summary:
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 or disease Intervention/treatment Phase
Systemic Scleroderma Systemic Sclerosis Radiation: UVA1 Other: UVA1 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00628797

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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
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Principal Investigator: Nicolas Hunzelmann University of Cologne, Dept. of Dermatology
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Responsible Party: Nicolas Hunzelmann, Prof. Dr. N. Hunzelmann, University of Cologne Identifier: NCT00628797    
Other Study ID Numbers: 07-200
First Posted: March 5, 2008    Key Record Dates
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:
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Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases