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

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

Official Title
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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

Conditions
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Calcinosis Cutis

Intervention / Treatment
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* Drug: Sodium Thiosulfate
* Other: Saline Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel two-arm study comparing sodium thiosulfate and saline control.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcinosis cutis, sodium thiosulfate, sodium chloride