Calcinosis CutisPhase 4NCT03639779
Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
A Phase 4 study testing Sodium Thiosulfate and Saline Solution in people with Calcinosis Cutis, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calcinosis Cutis
- What is being tested?
- Sodium Thiosulfate and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Calcinosis Cutis
- Being tested
- Sodium Thiosulfate, Saline Solution
- Keywords
- Calcinosis cutis, sodium thiosulfate, sodium chloride
- Medical subject headings
- Calcinosis Cutis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ThiosulfateDrug
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
Saline SolutionOther
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
| Study group | Role | What they receive |
|---|---|---|
| Sodium thiosulfate | Experimental | 50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment. Receives: Drug: Sodium Thiosulfate |
| Saline solution | Placebo comparator | 30 ml vials of sodium chloride 0.9% will be used for the control treatment. Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Size
The lesion size is measured in square centimeters.
Measured: 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).
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start2 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Time and resource constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Calcinosis CutisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel two-arm study comparing sodium thiosulfate and saline control.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Weinstein, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639779
- Sponsor's protocol ID
- BIO-18-14095
- Status last verified
- Jun 2021
- First submitted
- 17 Aug 2018
- Last updated
- 1 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03639779
- Acronym / sponsor ID
- BIO-18-14095
- Conditions
- Calcinosis Cutis
- Keywords
- Calcinosis cutis, sodium thiosulfate, sodium chloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Time and resource constraints
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 1 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a parallel two-arm study comparing sodium thiosulfate and saline control.
| Arm | Type | Receives |
|---|---|---|
| Sodium thiosulfate | Experimental | Drug: Sodium Thiosulfate50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment. |
| Saline solution | Placebo comparator | Other: Saline Solution30 ml vials of sodium chloride 0.9% will be used for the control treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium ThiosulfateA volume of 0.1 ml/cm2 of STS will be injected into each lesion. | Drug | Sodium thiosulfate |
| Saline SolutionA volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion. | Other | Saline solution |
Primary outcome
Lesion Size
Time frame: 3 months
The lesion size is measured in square centimeters.
Physician Global Assessment (PGA)
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Thiosulfate and Saline Solution in people with Calcinosis Cutis, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Size (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.