NCT03639779

Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis

A Comparative Study of the Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Normal Saline for the Treatment of Dystrophic and Idiopathic Calcinosis Cutis, A Double-Blind Randomized Placebo-Controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Central Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Type	Name	Description
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.

Timeline

• Start date: 2018-11-02
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-08-21
• Last updated: 2021-07-01
• Results posted: 2021-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study