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Topical Sodium Thiosulfate and Laser for Calcinosis in Dermatomyositis
NCT01572844Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2012
- Primary completion
- Jun 2016
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- sodium thiosulfate
- Conditions
- calcinosis
01
Overview
Phase 2, open-label trial of sodium thiosulfate in calcinosis (2 arms). Primary endpoint: Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales at 20 weeks. Started Aug 2012; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Treatment Lesion
Lesion treated with FCO2 Laser + Topical Sodium Thiosulfate
Control Lesion
Lesion receiving no treatment (internal control)
03
Who it enrols
Adults 18-65 with adult or juvenile dermatomyositis and stable calcinosis who have failed at least one prior therapy. Excludes active infection, pregnancy, and severe systemic disease.
04
Endpoints
Primary
Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales
Secondary
Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Hardness as Measured by a Difference in Durometer Measurements
Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales
Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies
Change in Patient Functionality and/or Quality of Life
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