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

Sponsor
Nicolas Hunzelmann (Other)
Overall Status
Terminated
CT.gov ID
NCT00628797
Collaborator
University Hospital Tuebingen (Other)
9
Enrollment
2
Locations
2
Arms
69
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: UVA1
  • Other: UVA1
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2008
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • Ultraviolet light

    		•
    Experimental: A UVA1

    Radiation: UVA1
    intraindividual half body irradiation
    Other Names:
  • ultraviolet light

    • Other: UVA1
    60 J/cm2 at least 36 tx
    Other Names:
  • Ultraviolet light

    		•

    Outcome Measures

    Primary Outcome Measures

    1. modified skin score [3 months]

    Secondary Outcome Measures

    1. modified skin score [6 months]

    2. histologic examination [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Tuebingen, Dept. of Dermatology Tuebingen BW Germany 72076
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicolas Hunzelmann, Prof. Dr. N. Hunzelmann, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT00628797
    Other Study ID Numbers:
    • 07-200
    First Posted:
    Mar 5, 2008
    Last Update Posted:
    May 31, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Nicolas Hunzelmann, Prof. Dr. N. Hunzelmann, University of Cologne
    systemic sclerosis
    skin fibrosis
    Additional relevant MeSH terms:
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Sclerosis

    Study Results

    No Results Posted as of May 31, 2017