Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
NCT03639779 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2021-07-01
Summary
The purpose of our research is to compare the effectiveness of 125mg/50ml sodium thiosulfate (STS) solution to normal saline (0.9% sodium chloride) when injected intralesionally for the treatment of calcinosis cutis. Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.
Conditions
- Calcinosis Cutis
Interventions
- DRUG
-
Sodium Thiosulfate
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
- OTHER
-
Saline Solution
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Sponsors & Collaborators
-
University of Central Florida
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-11-02
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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