Subcutaneous Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study.
- Conditions
- Patient presenting with:- ectopic ossification secondary to iPPSD2 or- ectopic calcification secondary to dermatomyositis or- ectopic calcification secondary to systemic sclerosisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2024-511620-13-00
- Lead Sponsor
- Centre Hospitalier Et Universitaire De Limoges
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Patient presenting with ectopic calcification secondary to dermatomyositis or ectopic calcification secondary to systemic sclerosis And aged 18 years old or higher or ectopic ossification secondary to iPPSD2 And aged = 2 years old and = 30 years old, 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). Contraception will be extended up to one month after the last injection. 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 (or beneficiary of) the social security system
Allergy to STS, sulfites 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), Adult patient unable to give consent, Patient placed under judicial protection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method