Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)

Sodium Thiosulfate Clinical Trial

Official title:

Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979378
• Other study ID #: CATSSO
• Status: Recruiting
• Start date: February 2015
• Est. completion date: February 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date.

Indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results.

Sodium thiosulfate (STS) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. More recently, STS has been reported in the treatment of renal calcification. vascular or even subcutaneous. First prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications.

For several months, a magistral preparation in the form of ointment based on STS has been developed by the pharmacy of Limoges University Hospital in order to combine the local effect of STS while avoiding the side effects of an administration of this treatment by systemic way. The first uses of this preparation appear promising and some preliminary results have already been published. The benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the FDA and the World Health Organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• any patient treated with sodium thiosulfate dermally provided by the pharmacy of Limoges University Hospital.

• availability of an objective imaging evaluation to compare the volume or surface of calcifications (or ossifications) treated (on two orthogonal incidences) before and after 6 months of treatment application.

• consent to participation in the study signed by the patient or by one of the holders of parental authority in the case of a minor patient.

Exclusion Criteria:

• calcification with concomitant cutaneous rupture which can allow an externalization of the calcium material by mechanical effects.

• Patient with calcification secondary to one of the following pathologies:

• diabetes

• chronic renal failure

• iatrogenic origin

Related Conditions & MeSH terms

• Calcinosis
• Ectopic Ossification
• Ossification, Heterotopic
• Sodium Thiosulfate

Locations

Country	Name	City	State
France	Grenoble university hospital	Grenoble
France	Kremlin Bicetre Hospital	Le Kremlin-Bicêtre
France	CHU de Limoges	Limoges
France	HEGP	Paris
France	Lariboisière Hospital	Paris
France	Necker Hospital	Paris
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcification/Ossification volume	Percentage decrease in the volume or surface area of calcifications (or ossification) treated on imaging of the same type performed before and 6 months after dermal STS use.	Month 6
Secondary	Change in aesthetic evolution from baseline at 6 month	aesthetic evolution on picture	Day 0, Month 6
Secondary	Change in pain from baseline at 6 month	Evaluation of pain with scale VAE (visual analog evaluation)	Day 0, Month 6
Secondary	Change of the quality of life from baseline at 6 month	evolution of the quality of life with Skindex scale	Day 0, Month 6
Secondary	local or general side effects	Number and nature of local or general side effects	Month 6