Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study.

Phase 1

• Conditions: Patient presenting with: - ectopic ossification secondary to iPPSD2 or - ectopic calcification secondary to dermatomyositis or - ectopic calcification secondary to systemic sclerosis; MedDRA version: 20.0 Level: LLT Classification code 10006935 Term: Calcification and ossification, unspecified System Organ Class: 100000004867; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-001978-22-FR
• Lead Sponsor: CHU de LIMOGES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

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 = 17 years old
And after the specific authorization of ANSM and CPP
- Indication of STS injection 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.
- Informed consent signed by the patient / parents
- Patient affiliated to (or beneficiary of) the social security system

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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)
- Patient unable to give consent
- Patient placed under judicial protection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified