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

• Sponsor: University of Central Florida (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03639779
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a parallel two-arm study comparing sodium thiosulfate and saline control.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: Nov 2, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Lesion Size [3 months]

   The lesion size is measured in square centimeters.

2. Physician Global Assessment (PGA) [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 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCF Health Lake Nona Office	Orlando	Florida	United States	32832

Sponsors and Collaborators

• University of Central Florida

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 15, 2019
• Informed Consent Form - May 21, 2019

More Information

Publications

None provided.

• Responsible Party: David Weinstein, Assistant Professor of Dermatology, University of Central Florida
• ClinicalTrials.gov Identifier: NCT03639779
• Other Study ID Numbers: BIO-18-14095
• First Posted: Aug 21, 2018
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Assistant Professor of Dermatology, University of Central Florida: Calcinosis cutis; sodium thiosulfate; sodium chloride
• Additional relevant MeSH terms: Calcinosis; Sodium thiosulfate

Study Results

Participant Flow

Pre-assignment Detail	The study had to be close early due to lack of support and time resulting in a lower number of participants than hoped for. 5 participants began the study, 1 was lost to follow-up. Each participant had 2 study lesions, each assigned to a different study arm.

Arm/Group Title	All Paticipants
Arm/Group Description	All study participants received an injection of Sodium Thiosulfate into one lesion. They received an injection of saline in the control lesion 50 ml vials of sodium thiosulfate (250mg/ml) were used for treatment. 30 ml vials of sodium chloride 0.9% will be used for the control treatment. A volume of 0.1 ml/cm2 of STS or normal will be injected into each lesion.
Period Title: Overall Study
STARTED	5
Baseline	5
Month 1	5
Month 2	4
Month 3	4
COMPLETED	4
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All study participants received an injection of Sodium Thiosulfate into one lesion. They received an injection of saline in the control lesion.
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 60%
>=65 years	2 40%
Sex: Female, Male (Count of Participants)
Female	4 80%
Male	1 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	5 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Lesion Size
Description	The lesion size is measured in square centimeters.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

One participant was lost to follow up

Arm/Group Title	Sodium Thiosulfate	Saline Solution
Arm/Group Description	50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment. Sodium Thiosulfate: A volume of 0.1 ml/cm2 of STS will be injected into each lesion.	30 ml vials of sodium chloride 0.9% will be used for the control treatment. Saline Solution: A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Measure Participants	5	5
Baseline	2.8	1.8
3 Months	3	3.0

2. Primary Outcome

Title	Physician Global Assessment (PGA)
Description	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).
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

One participant was lost to follow up.

Arm/Group Title	Sodium Thiosulfate	Saline Solution
Arm/Group Description	50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment. Sodium Thiosulfate: A volume of 0.1 ml/cm2 of STS will be injected into each lesion.	30 ml vials of sodium chloride 0.9% will be used for the control treatment. Saline Solution: A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Measure Participants	5	5
Baseline	4	4
3 Month	3	3.25

3. Primary Outcome

Title	Visual Analog Scale (VAS) for Pain
Description	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).
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

One participant was lost to follow up.

Arm/Group Title	Sodium Thiosulfate	Saline Solution
Arm/Group Description	50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment. Sodium Thiosulfate: A volume of 0.1 ml/cm2 of STS will be injected into each lesion.	30 ml vials of sodium chloride 0.9% will be used for the control treatment. Saline Solution: A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Measure Participants	5	5
Mean (Full Range) [score on a scale]	3.6	2.6

Adverse Events

Time Frame	3 months
Arm/Group Title	Sodium Thiosulfate		Saline Solution
Arm/Group Description	50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment. Sodium Thiosulfate: A volume of 0.1 ml/cm2 of STS will be injected into each lesion.		30 ml vials of sodium chloride 0.9% will be used for the control treatment. Saline Solution: A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
All Cause Mortality
	Sodium Thiosulfate		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Serious Adverse Events
	Sodium Thiosulfate		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Sodium Thiosulfate		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)

Limitations/Caveats

The study had to be closed early due to lack up support/resources.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.