An observational study in Sodium Thiosulfate and Ectopic Ossification, sponsored by University Hospital, Limoges. Status unknown at 7 sites in France. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2019-06-11.
Sponsored by University Hospital, Limoges · Observational
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.
33 studies on the registry are indexed under Ossification, Heterotopic; 9 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 11 observational studies indexed under Ossification, Heterotopic.
Browse Ossification, Heterotopic studies →University Hospital, Limoges is the lead sponsor of 262 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patient with ectopic calcification / ossification
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Exclusion Criteria:
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.
Time frame: Month 6
Change in aesthetic evolution from baseline at 6 month
aesthetic evolution on picture
Time frame: Day 0, Month 6
Change in pain from baseline at 6 month
Evaluation of pain with scale VAE (visual analog evaluation)
Time frame: Day 0, Month 6
Change of the quality of life from baseline at 6 month
evolution of the quality of life with Skindex scale
Time frame: Day 0, Month 6
local or general side effects
Number and nature of local or general side effects
Time frame: Month 6
Started Feb 2015 (actual). Primary completion is estimated for Feb 2020, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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