## Protocol Section
### Identification Module
**NCT ID:** NCT03639779

**Brief Title:** Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis

**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

#### Organization Study ID Info
**ID:** BIO-18-14095
#### Organization
**Class:** OTHER
**Full Name:** University of Central Florida
### Status Module
#### Completion Date
**Date:** 2019-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-07-01

**Type:** ACTUAL

**Last Update Submit Date:** 2021-06-29

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2019-12-31

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-07-01

**Type:** ACTUAL

**Results First Submit Date:** 2021-05-15

**Results First Submit QC Date:** 2021-06-29

#### Start Date
**Date:** 2018-11-02

**Type:** ACTUAL

**Status Verified Date:** 2021-06

#### Study First Post Date
**Date:** 2018-08-21
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-17
**Study First Submit QC Date:** 2018-08-17
**Why Stopped:** Time and resource constraints
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Central Florida

#### Responsible Party

**Investigator Affiliation:** University of Central Florida

**Investigator Full Name:** David Weinstein

**Investigator Title:** Assistant Professor of Dermatology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Calcinosis Cutis

**Keywords:**

- Calcinosis cutis

- sodium thiosulfate

- sodium chloride

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This is a parallel two-arm study comparing sodium thiosulfate and saline control.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 5

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.

**Intervention Names:**

- Drug: Sodium Thiosulfate

**Label:** Sodium thiosulfate

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 30 ml vials of sodium chloride 0.9% will be used for the control treatment.

**Intervention Names:**

- Other: Saline Solution

**Label:** Saline solution

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sodium thiosulfate

**Description:** A volume of 0.1 ml/cm2 of STS will be injected into each lesion.

**Name:** Sodium Thiosulfate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Saline solution

**Description:** A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.

**Name:** Saline Solution

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The lesion size is measured in square centimeters.

**Measure:** Lesion Size

**Time Frame:** 3 months

**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).

**Measure:** Physician Global Assessment (PGA)

**Time Frame:** 3 months

**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).

**Measure:** Visual Analog Scale (VAS) for Pain

**Time Frame:** 3 months

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Orlando

**Country:** United States

**Facility:** UCF Health Lake Nona Office

**State:** Florida

**Zip:** 32832

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-05-15

- Filename: Prot_SAP_002.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 301394

- Type Abbrev: Prot_SAP

- Upload Date: 2021-06-09T10:45

- Date: 2019-05-21

- Filename: ICF_003.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 251745

- Type Abbrev: ICF

- Upload Date: 2021-06-09T10:46

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002128

- Term: Calcium Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M5377

- Name: Calcinosis

- Relevance: HIGH

- As Found: Calcinosis

- ID: M2903

- Name: Calcinosis Cutis

- Relevance: HIGH

- As Found: Calcinosis Cutis

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5391

- Name: Calcium Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000092182

- Term: Calcinosis Cutis

- ID: D000002114

- Term: Calcinosis

### Intervention Browse Module - Ancestors

- ID: D000000931

- Term: Antidotes

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000995

- Term: Antitubercular Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000002614

- Term: Chelating Agents

- ID: D000064449

- Term: Sequestering Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M256801

- Name: Sodium thiosulfate

- Relevance: HIGH

- As Found: C-reactive protein

- ID: M4250

- Name: Antidotes

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5860

- Name: Chelating Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000017717

- Term: Sodium thiosulfate

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2021-06-10

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Sodium Thiosulfate

**Deaths Num At Risk:** 5

**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.

**ID:** EG000

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** Sodium Thiosulfate

**Group ID:** EG001

**Title:** Saline Solution

**Deaths Num At Risk:** 5

**Description:** 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.

**ID:** EG001

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** Saline Solution

**Frequency Threshold:** 0

**Time Frame:** 3 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 5

**Units:** Participants

### Group

**ID:** BG000

**Title:** All Participants

**Description:** All study participants received an injection of Sodium Thiosulfate into one lesion. They received an injection of saline in the control lesion.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** The study had to be closed early due to lack up support/resources.
### Point of Contact
**Email:** david.weinstein@ucf.edu
**Organization:** University of Central Florida College of Medicine
**Phone:** (407)266-4900
**Title:** Dr. David Weinstein
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.4
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 1.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 3.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 4
**Units:** Participants
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 3.25
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 4
**Units:** Participants
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.4
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 3.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 6.6
- **Value:** 2.6
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The lesion size is measured in square centimeters.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** One participant was lost to follow up
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** Lesion Size
**Type:** PRIMARY
**Unit of Measure:** cm^2
##### 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.
**ID:** OG000
**Title:** Sodium Thiosulfate
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Saline Solution
#### Outcome Measure 2
**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).
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** One participant was lost to follow up.
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** Physician Global Assessment (PGA)
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### 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.
**ID:** OG000
**Title:** Sodium Thiosulfate
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Saline Solution
#### Outcome Measure 3
**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).
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** One participant was lost to follow up.
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** Visual Analog Scale (VAS) for Pain
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### 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.
**ID:** OG000
**Title:** Sodium Thiosulfate
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Saline Solution
### Participant Flow Module
#### 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.
**ID:** FG000
**Title:** All Paticipants
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
**Number of Units:** 10
##### Milestone
**Type:** Baseline
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
**Number of Units:** 10
##### Milestone
**Type:** Month 1
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
**Number of Units:** 10
##### Milestone
**Type:** Month 2
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
**Number of Units:** 8
##### Milestone
**Type:** Month 3
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
**Number of Units:** 8
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
**Number of Units:** 8
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Number of Units:** 2
**Pre-Assignment Details:** 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.
**Type Units Analyzed:** Lesions
**Has Results:** True