Status:
WITHDRAWN
A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis
Lead Sponsor:
Loyola University
Conditions:
Calcinosis Cutis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Calcinosis cutis refers to a group of disorders characterized by calcium deposition in the skin (1). The disorders are classified according to etiology into the following types: dystrophic, metastatic...
Eligibility Criteria
Inclusion
- Patients seen by the Division of Rheumatology at Loyola Outpatient Center in Maywood, Illinois (IL), Oak Brook Terrace Outpatient Center in Oakbrook, IL, and Burr Ridge Outpatient Center in Burr Ridge, IL.
- Male and female patients 18 years old and above
- Patients with at least 2 distinct calcinosis cutis lesions separated by at least 10 inches, that are a minimum of 2 millimeters (mm) in diameter, and identifiable on physical exam and ultrasound, such that one lesion may be used as an internal control lesion
- Patients on calcium channel blockers, bisphosphonates, prednisone, and colchicine will be included
Exclusion
- Patients with calcinosis cutis lesions that appear actively infected (i.e., exhibiting purulent drainage and malodor) will not be included
- Patient with concomitant use of systemic intravenous sodium thiosulfate for treatment of calciphylaxis will not be included
- Patients with hypercalcemia will not be included
- Patients who are pregnant or breastfeeding will not be included
- Patients who are allergic to sulfa and/or zinc will not be included
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01918904
Start Date
September 1 2013
End Date
September 1 2013
Last Update
November 17 2016
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