Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
NCT ID: NCT03639779
Last Updated: 2021-07-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
5 participants
INTERVENTIONAL
2018-11-02
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sodium thiosulfate
50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.
Sodium Thiosulfate
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
Saline solution
30 ml vials of sodium chloride 0.9% will be used for the control treatment.
Saline Solution
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Interventions
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Sodium Thiosulfate
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
Saline Solution
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Eligibility Criteria
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Inclusion Criteria
* Must have health insurance will be eligible to participate
* Must have a current diagnosis of dystrophic or idiopathic calcinosis cutis
* Subjects must have at least 2 lesions of at least 2mm in size
Exclusion Criteria
* Allergy to any component of the sodium thiosulfate solution
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Women who are breastfeeding
* Prisoners
18 Years
ALL
Yes
Sponsors
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University of Central Florida
OTHER
Responsible Party
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David Weinstein
Assistant Professor of Dermatology
Locations
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UCF Health Lake Nona Office
Orlando, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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BIO-18-14095
Identifier Type: -
Identifier Source: org_study_id
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