Calcinosis Cutis
Conditions
Keywords
Calcinosis cutis, sodium thiosulfate, sodium chloride
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.
Interventions
DRUGSodium Thiosulfate
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
OTHERSaline Solution
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Sponsors
University of Central Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a parallel two-arm study comparing sodium thiosulfate and saline control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Size | 3 months | The lesion size is measured in square centimeters. |
| 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). |
| 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). |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All study participants received an injection of Sodium Thiosulfate into one lesion. They received an injection of saline in the control lesion. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Lesion Size
The lesion size is measured in square centimeters.
Time frame: 3 months
Population: One participant was lost to follow up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sodium Thiosulfate | Lesion Size | Baseline | 2.8 cm^2 |
| Sodium Thiosulfate | Lesion Size | 3 Months | 3 cm^2 |
| Saline Solution | Lesion Size | Baseline | 1.8 cm^2 |
| Saline Solution | Lesion Size | 3 Months | 3.0 cm^2 |
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).
Time frame: 3 months
Population: One participant was lost to follow up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sodium Thiosulfate | Physician Global Assessment (PGA) | 3 Month | 3 score on a scale |
| Sodium Thiosulfate | Physician Global Assessment (PGA) | Baseline | 4 score on a scale |
| Saline Solution | Physician Global Assessment (PGA) | Baseline | 4 score on a scale |
| Saline Solution | Physician Global Assessment (PGA) | 3 Month | 3.25 score on a scale |
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).
Time frame: 3 months
Population: One participant was lost to follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sodium Thiosulfate | Visual Analog Scale (VAS) for Pain | 3.6 score on a scale |
| Saline Solution | Visual Analog Scale (VAS) for Pain | 2.6 score on a scale |