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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

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ClinicalTrials.gov Identifier: NCT03639779
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
David Weinstein, University of Central Florida

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.

Condition or disease Intervention/treatment Phase
Calcinosis Cutis Drug: Sodium Thiosulfate Other: Saline Solution Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a parallel two-arm study comparing sodium thiosulfate and saline control.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium thiosulfate
50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.
Drug: Sodium Thiosulfate
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.

Placebo Comparator: Saline solution
30 ml vials of sodium chloride 0.9% will be used for the control treatment.
Other: Saline Solution
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.




Primary Outcome Measures :
  1. Lesion Size [ Time Frame: 3 months ]
    The lesion size is measured in centimeters.

  2. Physician Global Assessment (PGA) [ Time Frame: 3 months ]
    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. Visual Analog Scale (VAS) for Pain [ Time Frame: 3 months ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639779


Contacts
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Contact: David Weinstein, MD 407-266-4900 david.weinstein@ucf.edu

Locations
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United States, Florida
UCF Health Lake Nona Office Recruiting
Orlando, Florida, United States, 32832
Contact: David Weinstein, MD    407-266-4900    david.weinstein@ucf.edu   
Principal Investigator: David Weinstein, MD         
Sponsors and Collaborators
University of Central Florida

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Responsible Party: David Weinstein, Assistant Professor of Dermatology, University of Central Florida
ClinicalTrials.gov Identifier: NCT03639779     History of Changes
Other Study ID Numbers: BIO-18-14095
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by David Weinstein, University of Central Florida:
Calcinosis cutis
sodium thiosulfate
sodium chloride

Additional relevant MeSH terms:
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Sodium thiosulfate
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents