Effectiveness of UVA1-irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis
Phase 1
Terminated
- Conditions
- Systemic SclerodermaSystemic Sclerosis
- Interventions
- Other: UVA1
- Registration Number
- NCT00628797
- Lead Sponsor
- Nicolas Hunzelmann
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A UVA1 B no UVA1 UVA1 half body irradiation with random allocation right and left; after three months of treatment treatment of both sides A UVA1 UVA1 -
- Primary Outcome Measures
Name Time Method modified skin score 3 months
- Secondary Outcome Measures
Name Time Method modified skin score 6 months histologic examination 3 months
Trial Locations
- Locations (2)
University of Tuebingen, Dept. of Dermatology
🇩🇪Tuebingen, BW, Germany
University of Cologne, Dept. of Dermatology
🇩🇪Cologne, NRW, Germany