Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

Launched by UNIVERSITY HOSPITAL, LIMOGES · Jun 27, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called sodium thiosulfate (STS) to treat ectopic calcifications or ossifications, which are hard deposits that can form in soft tissues due to certain conditions like systemic sclerosis or dermatomyositis. These hard deposits can cause significant pain and affect a patient's quality of life. Currently, there are no approved medical treatments for this issue, and surgery is often the only option when the deposits become too large or problematic. The trial aims to see if STS, which has been used safely for other medical purposes, can be effective and safe when injected directly into the affected areas.

To be eligible for this trial, participants need to be at least 2 years old and have ectopic calcifications or ossifications related to specific conditions. They should not have plans for surgery on these deposits in the next year and must agree to use effective contraception if they are sexually active. Participants will receive injections of STS and will be monitored for any side effects and improvements in their condition. This trial is an important step in exploring a new treatment option for these challenging medical issues.

Gender

ALL

Eligibility criteria

• 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