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Time and resource constraints
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium thiosulfate | Experimental | 50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment. |
|
| Saline solution | Placebo Comparator | 30 ml vials of sodium chloride 0.9% will be used for the control treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Thiosulfate | Drug | A volume of 0.1 ml/cm2 of STS will be injected into each lesion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Size | The lesion size is measured in square centimeters. | 3 months |
| Physician Global Assessment (PGA) | 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 months |
| Visual Analog Scale (VAS) for Pain | 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). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCF Health Lake Nona Office | Orlando | Florida | 32832 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All study participants received an injection of Sodium Thiosulfate into one lesion. They received an injection of saline in the control lesion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lesion Size | The lesion size is measured in square centimeters. | One participant was lost to follow up | Posted | Mean | Full Range | cm^2 | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Thiosulfate | 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. |
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The study had to be closed early due to lack up support/resources.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Weinstein | University of Central Florida College of Medicine | (407)266-4900 | david.weinstein@ucf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2019 | Jun 9, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2019 | Jun 9, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000092182 | Calcinosis Cutis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
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| ID | Term |
|---|---|
| C017717 | sodium thiosulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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This is a parallel two-arm study comparing sodium thiosulfate and saline control.
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| Saline Solution | Other | A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Physician Global Assessment (PGA) | 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). | One participant was lost to follow up. | Posted | Mean | Full Range | score on a scale | 3 months |
|
|
|
| Primary | Visual Analog Scale (VAS) for Pain | 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). | One participant was lost to follow up. | Posted | Mean | Full Range | score on a scale | 3 months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Saline Solution | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| 3 Month |
|
|