Could a simple injection dissolve painful calcium lumps in rare diseases?
NCT ID NCT03582800
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study tests whether injecting sodium thiosulfate directly into abnormal calcium deposits can shrink them and reduce pain. It includes people with three rare conditions: systemic sclerosis, dermatomyositis, and a genetic disorder called iPPSD2. Participants receive up to 11 injections over six months, and doctors measure changes in deposit size using CT scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sodium thiosulfate injected under the skin
- What this could lead to
- If it works, this could offer a non-surgical option to shrink painful calcium deposits in rare diseases like systemic sclerosis and dermatomyositis.
- What could go wrong
- This is a small, early-phase pilot study with no placebo group, so results may not be definitive. The injections may not shrink deposits or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient presenting with: * ectopic ossification secondary to iPPSD2 or * ectopic calcification secondary to dermatomyositis or * ectopic calcification secondary to systemic sclerosis * Patient aged 2 years or over * Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and/or functional impact of the targeted calcification/ossification * Patient with no planned surgery of the calcifications/ossifications for the twelve coming months * Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence) * Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection. * Informed consent signed by the patient / parents * Patient affiliated to the social security system Exclusion Criteria: * Allergy to STS or one of the excipients used * Contraindication to local injection of STS * Anticoagulant therapy * Pregnant, parturient or breastfeeding woman * Patient deprived of freedom by a court judgment or an administrative decision * Patient undergoing psychiatric care under coercion * Legally protected adult patients (guardianship / curatorship) * Patient unable to give consent * Patient placed under judicial protection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ApHp - Hôpital Bicêtre
RECRUITINGLe Kremlin-Bicêtre, 94270, France
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ApHp - hôpital Lariboisière
RECRUITINGParis, 75000, France
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CHU de BORDEAUX
RECRUITINGBordeaux, 33000, France
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CHU de Limoges
RECRUITINGLimoges, 87042, France
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CHU de ROUEN
NOT_YET_RECRUITINGRouen, 76031, France
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CHU de Toulouse
RECRUITINGToulouse, 31000, France
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Hospice Civil de Lyon
NOT_YET_RECRUITINGBron, 69500, France
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Hôpital de la Pitié Salpétriêre
NOT_YET_RECRUITINGParis, 75651, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase IIa, randomized, parallel, Double-Blind, placebo controlled study to evaluate the efficacy and safety of enpatoran in dermatomyositis and polymyositis participants receiving standard of care (NEPTUNIA)
- Can a new pill ease muscle weakness in myositis?
- Can a single drug tame multiple autoimmune diseases?
- Can better sleep ease pain in teens with rheumatic disease?
- Immune clues in the blood may foretell heart trouble
- Can a targeted immune drug calm rare muscle inflammation?