NCT03639779

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

Terminated Phase 4 Results posted Last updated 1 July 2021

What this trial tests

Phase 4 trial testing Sodium Thiosulfate in Calcinosis Cutis in 5 participants. Terminated before completion.

Timeline

2 November 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University of Central Florida
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	5
Start date	2 November 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Sodium Thiosulfate (SODIUM THIOSULFATE) — full drug profile →
• Saline Solution

Conditions studied

• Calcinosis Cutis — all drugs for Calcinosis Cutis →

Sponsor

University of Central Florida

Who can join

18 and older, any sex, with Calcinosis Cutis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lesion Size Primary · 3 months

The lesion size is measured in square centimeters.

Baseline

Group	Value	95% CI
Sodium Thiosulfate	2.8	0.1 – 4
Saline Solution	1.8	0.4 – 4

3 Months

Group	Value	95% CI
Sodium Thiosulfate	3	0 – 4
Saline Solution	3.0	0.1 – 4

Physician Global Assessment (PGA) Primary · 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).

Baseline

Group	Value	95% CI
Sodium Thiosulfate	4	4 – 4
Saline Solution	4	4 – 4

3 Month

Group	Value	95% CI
Sodium Thiosulfate	3	0 – 4
Saline Solution	3.25	1 – 4

Visual Analog Scale (VAS) for Pain Primary · 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).

Group	Value	95% CI
Sodium Thiosulfate	3.6	0.4 – 10
Saline Solution	2.6	0 – 6.6

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vascular smooth muscle cells in intimal hyperplasia, an update.
   Déglise S, Bechelli C, Allagnat F. · · 2022 · cited 79× · PMID 36685215 · DOI 10.3389/fphys.2022.1081881
2. Clinical Potential of Hydrogen Sulfide in Peripheral Arterial Disease.
   Bechelli C, Macabrey D, Deglise S, Allagnat F. · · 2023 · cited 8× · PMID 37373103 · DOI 10.3390/ijms24129955
3. Clinical Use of Hydrogen Sulfide to Protect Against Intimal Hyperplasia.
   Macabrey D, Longchamp A, Déglise S, Allagnat F. · · 2022 · cited 7× · PMID 35479275 · DOI 10.3389/fcvm.2022.876639
4. Hydrogen sulfide aggravates neutrophil infiltration, vascular remodeling and elastase-induced abdominal aortic aneurysm in male mice.
   Bechelli C, Macabrey D, Caloz F, Urfer S, et al · · 2025 · cited 1× · PMID 40593101 · DOI 10.1038/s43856-025-00978-5