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

June 29, 2021 updated by: David Weinstein, University of Central Florida

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32832
        • UCF Health Lake Nona Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium thiosulfate
50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.
Drug: Sodium Thiosulfate
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
Placebo Comparator: Saline solution
30 ml vials of sodium chloride 0.9% will be used for the control treatment.
Other: Saline Solution
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion Size
Time Frame: 3 months
The lesion size is measured in square centimeters.
3 months
Physician Global Assessment (PGA)
Time Frame: 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).
3 months
Visual Analog Scale (VAS) for Pain
Time Frame: 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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-18-14095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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