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

Phase 4

Terminated

• Conditions: Calcinosis Cutis
• Interventions: Drug: Sodium Thiosulfate; Other: Saline Solution

• Registration Number: NCT03639779
• Lead Sponsor: University of Central Florida

Brief 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.

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2018-11-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Results First Submitted: 2021-05-15
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Results First Posted: 2021-07-01
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Male or female adult 18 years of age or older
• 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

• Unable to read and speak English
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium thiosulfate	Sodium Thiosulfate	50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.
Saline solution	Saline Solution	30 ml vials of sodium chloride 0.9% will be used for the control treatment.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Pain	3 months	The VAS for pain is used to assess the pain associated with the lesion. The pain will be recorded as a number from 1 (no pain) to 10 (severe pain).
Physician Global Assessment (PGA)	3 months	The PGA will be done by the physician to assess appearance and changes in the lesion. The lesion will be assigned a score from 0 (clear) to 4 (severe).
Lesion Size	3 months	The lesion size is measured in square centimeters.

Trial Locations

Locations (1)

UCF Health Lake Nona Office; 🇺🇸 Orlando, Florida, United States