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

NCT03639779 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: BIO-18-14095
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcinosis Cutis

Keywords

Calcinosis cutis; sodium thiosulfate; sodium chloride

Outcome Measures

Primary Outcomes (3)

• Lesion Size

  The lesion size is measured in square centimeters.

  3 months

• 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).

  3 months

• 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).

  3 months

Study Arms (2)

Sodium thiosulfate

EXPERIMENTAL

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

Drug: Sodium Thiosulfate

Saline solution

PLACEBO COMPARATOR

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

Other: Saline Solution

Interventions

Sodium Thiosulfate DRUG

A volume of 0.1 ml/cm2 of STS will be injected into each lesion.

Sodium thiosulfate

Saline Solution OTHER

A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

UCF Health Lake Nona Office

Orlando, Florida, 32832, United States

Location

MeSH Terms

Conditions

Calcinosis Cutis

Interventions

sodium thiosulfate; Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The study had to be closed early due to lack up support/resources.

Results Point of Contact

• Title: Dr. David Weinstein
• Organization: University of Central Florida College of Medicine

david.weinstein@ucf.edu

(407)266-4900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Model Details: This is a parallel two-arm study comparing sodium thiosulfate and saline control.

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: November 2, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 1, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)