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

Calcinosis Cutis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03639779
• Other study ID #: BIO-18-14095
• Status: Terminated
• Phase: Phase 4
• Start date: November 2, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2021
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Calcinosis Cutis

Intervention

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.

Locations

Country	Name	City	State
United States	UCF Health Lake Nona Office	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion Size	The lesion size is measured in square centimeters.	3 months
Primary	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
Primary	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