Efficacy of intralesional sodium thiosulfate for the treatment of dystrophic calcinosis cutis: A double-blind, placebo-controlled pilot study.

Background: Intralesional injection of sodium thiosulfate has emerged as a promising therapy for calcinosis cutis, but to our knowledge there are no randomized controlled trials evaluating its efficacy as a treatment.

Objective: Conduct a prospective, double-blinded investigation of intralesional sodium thiosulfate versus normal saline in the treatment of dystrophic calcinosis cutis.

Methods: This prospective pilot study injected normal saline or sodium thiosulfate at 0.1 mL/cm2 into lesions at baseline and at 1- and 2-month follow-up. Subjects were followed for a total of 12 weeks. An in-person Physician Global Assessment score was assigned by the injecting physician at each visit and was repeated by an independent observer.

Results: Of 4 subjects who completed the study, only 1 experienced improvement in the size and Physician Global Assessment score of the lesion. By 3-month follow-up, there was no difference between the average size of the treatment and control lesions (P = .39).

Conclusions: This was a small single-center study with limited demographic diversity and a short follow-up period. Only dystrophic calcinosis cutis subjects were included, and subjects received only 3 monthly injections of sodium thiosulfate. Conclusions: With only 1 positive response, our results highlight the need for further study of sodium thiosulfate treatment for dystrophic calcinosis.