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

University of Central Florida

Status and phase: Terminated; Phase 4

Conditions: Calcinosis Cutis

Treatments: Other: Saline Solution; Drug: Sodium Thiosulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03639779

BIO-18-14095

Details and patient eligibility

About

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.

Full description

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

5 participants in 2 patient groups, including a placebo group

Sodium thiosulfate

Experimental group

Description:

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

Treatment:

Drug: Sodium Thiosulfate

Saline solution

Placebo Comparator group

Description:

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

Treatment:

Other: Saline Solution