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/cm 2 into lesions at baseline and at 1- and 2 -month follow-up. Subjects were followed for a total of 12 weeks. An inperson 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). Limitations: 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. ( JAAD Int 2020;1:114-20.)