Study Stopped
lack of recruitement
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
1 other identifier
interventional
9
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2008
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 31, 2017
May 1, 2017
2.4 years
February 26, 2008
May 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified skin score
3 months
Secondary Outcomes (2)
modified skin score
6 months
histologic examination
3 months
Study Arms (2)
A UVA1 B no UVA1
OTHERhalf body irradiation with random allocation right and left; after three months of treatment treatment of both sides
A UVA1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- systemic sclerosis ACR criteria
- skin fibrosis at least involving the distal third of the lower arm
You may not qualify if:
- photosensitizing drugs
- recent UV therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nicolas Hunzelmannlead
- University Hospital Tuebingencollaborator
Study Sites (2)
University of Tuebingen, Dept. of Dermatology
Tübingen, Baden-Wurttemberg, 72076, Germany
University of Cologne, Dept. of Dermatology
Cologne, North Rhine-Westphalia, 50937, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Hunzelmann
University of Cologne, Dept. of Dermatology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. N. Hunzelmann
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 5, 2008
Study Start
February 1, 2008
Primary Completion
July 1, 2010
Study Completion
November 1, 2013
Last Updated
May 31, 2017
Record last verified: 2017-05