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

Primary Purpose

Calcinosis Cutis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sodium Thiosulfate
Saline Solution
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcinosis Cutis focused on measuring Calcinosis cutis, sodium thiosulfate, sodium chloride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCF Health Lake Nona Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sodium thiosulfate

Saline solution

Arm Description

50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.

30 ml vials of sodium chloride 0.9% will be used for the control treatment.

Outcomes

Primary Outcome Measures

Lesion Size
The lesion size is measured in square centimeters.
Physician Global Assessment (PGA)
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).
Visual Analog Scale (VAS) for Pain
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).

Secondary Outcome Measures

Full Information

First Posted
August 17, 2018
Last Updated
June 29, 2021
Sponsor
University of Central Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03639779
Brief Title
Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Time and resource constraints
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Florida

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcinosis Cutis
Keywords
Calcinosis cutis, sodium thiosulfate, sodium chloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a parallel two-arm study comparing sodium thiosulfate and saline control.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium thiosulfate
Arm Type
Experimental
Arm Description
50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
30 ml vials of sodium chloride 0.9% will be used for the control treatment.
Intervention Type
Drug
Intervention Name(s)
Sodium Thiosulfate
Intervention Description
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
Intervention Type
Other
Intervention Name(s)
Saline Solution
Intervention Description
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Primary Outcome Measure Information:
Title
Lesion Size
Description
The lesion size is measured in square centimeters.
Time Frame
3 months
Title
Physician Global Assessment (PGA)
Description
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).
Time Frame
3 months
Title
Visual Analog Scale (VAS) for Pain
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UCF Health Lake Nona Office
City
Orlando
State/Province
Florida
ZIP/Postal Code
32832
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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