Trial Outcomes & Findings for Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis (NCT NCT03639779)

NCT ID: NCT03639779

Last Updated: 2021-07-01

Results Overview

The lesion size is measured in square centimeters.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-07-01

Participant Flow

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.

Unit of analysis: Lesions

Participant milestones

Measure	All Paticipants 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.
Overall Study STARTED	5 10
Overall Study Baseline	5 10
Overall Study Month 1	5 10
Overall Study Month 2	4 8
Overall Study Month 3	4 8
Overall Study COMPLETED	4 8
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Measure	All Paticipants 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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 3 months

Population: One participant was lost to follow up

The lesion size is measured in square centimeters.

Outcome measures

Measure	Sodium Thiosulfate n=5 Participants 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.	Saline Solution n=5 Participants 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.
Lesion Size Baseline	2.8 cm^2 Interval 0.1 to 4.0	1.8 cm^2 Interval 0.4 to 4.0
Lesion Size 3 Months	3 cm^2 Interval 0.0 to 4.0	3.0 cm^2 Interval 0.1 to 4.0

PRIMARY outcome

Timeframe: 3 months

Population: One participant was lost to follow up.

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).

Outcome measures

Measure	Sodium Thiosulfate n=5 Participants 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.	Saline Solution n=5 Participants 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.
Physician Global Assessment (PGA) Baseline	4 score on a scale Interval 4.0 to 4.0	4 score on a scale Interval 4.0 to 4.0
Physician Global Assessment (PGA) 3 Month	3 score on a scale Interval 0.0 to 4.0	3.25 score on a scale Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: 3 months

Population: One participant was lost to follow up.

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).

Outcome measures

Measure	Sodium Thiosulfate n=5 Participants 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.	Saline Solution n=5 Participants 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.
Visual Analog Scale (VAS) for Pain	3.6 score on a scale Interval 0.4 to 10.0	2.6 score on a scale Interval 0.0 to 6.6

Adverse Events

Sodium Thiosulfate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Weinstein

University of Central Florida College of Medicine

Phone: (407)266-4900

Email: david.weinstein@ucf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place