TerminatedPhase 4

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

Stopped: Time and resource constraints

United States5 participantsStarted 2018-11-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Lesion Size

Timeframe: 3 months

Physician Global Assessment (PGA)

Timeframe: 3 months

Visual Analog Scale (VAS) for Pain

Timeframe: 3 months

Trial details

NCT IDNCT03639779

SponsorUniversity of Central Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

Results submitted2021-05-15

View on ClinicalTrials.gov More Calcinosis Cutis trials