Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis

Summary

This prospective placebo-controlled trial will enroll 20 patients with SSc and at least one calcinotic lesion of the hands that is palpable on physical examination and measurable on hand radiographs. Each subject will undergo a screening evaluation 1 month before treatment with the study drug is initiated. Each subject will be instructed to blindly self-apply either topical 25% sodium metabisulfite or placebo cream twice daily. In-person follow-up evaluations will be performed after 4-months, with monthly telehealth follow-up visits to ensure adherence and arrange study drug refill deliveries.

Timeline

Start

2024-01-02

Primary completion

2024-12-31

Completion

2024-12-31

Publications

• Background Ricardo JW, Sun HY, Gorji M, Sebaratnam DF. Topical sodium thiosulfate as treatment of calcinosis cutis: Case series and systematic review. J Am Acad Dermatol. 2022 Aug;87(2):443-444. doi: 10.1016/j.jaad.2021.09.013. Epub 2021 Sep 16. No abstract available.
• Background Valenzuela A, Baron M; Canadian Scleroderma Research Group; Herrick AL, Proudman S, Stevens W; Australian Scleroderma Interest Group; Rodriguez-Reyna TS, Vacca A, Medsger TA Jr, Hinchcliff M, Hsu V, Wu JY, Fiorentino D, Chung L. Calcinosis is associated with digital ulcers and osteoporosis in patients with systemic sclerosis: A Scleroderma Clinical Trials Consortium study. Semin Arthritis Rheum. 2016 Dec;46(3):344-349. doi: 10.1016/j.semarthrit.2016.05.008. Epub 2016 Jun 2.
• Background Valenzuela A, Baron M, Rodriguez-Reyna TS, Proudman S, Khanna D, Young A, Hinchcliff M, Steen V, Gordon J, Hsu V, Castelino FV, Schoenfeld S, Li S, Wu JY, Fiorentino D, Chung L. Calcinosis is associated with ischemic manifestations and increased disability in patients with systemic sclerosis. Semin Arthritis Rheum. 2020 Oct;50(5):891-896. doi: 10.1016/j.semarthrit.2020.06.007. Epub 2020 Jun 17.
• Background Cruz-Dominguez MP, Garcia-Collinot G, Saavedra MA, Medina G, Carranza-Muleiro RA, Vera-Lastra OL, Jara LJ. Clinical, biochemical, and radiological characterization of the calcinosis in a cohort of Mexican patients with systemic sclerosis. Clin Rheumatol. 2017 Jan;36(1):111-117. doi: 10.1007/s10067-016-3412-9. Epub 2016 Oct 7.
• Background Bartoli F, Fiori G, Braschi F, Amanzi L, Bruni C, Blagojevic J, Bellando-Randone S, Cometi L, de Souza Mueller C, Guiducci S, Rasero L, Epifani F, Furst DE, Matucci-Cerinic M. Calcinosis in systemic sclerosis: subsets, distribution and complications. Rheumatology (Oxford). 2016 Sep;55(9):1610-4. doi: 10.1093/rheumatology/kew193. Epub 2016 May 30.
• Background Gauhar R, Wilkinson J, Harris J, Manning J, Herrick AL. Calcinosis preferentially affects the thumb compared to other fingers in patients with systemic sclerosis. Scand J Rheumatol. 2016 Jul;45(4):317-20. doi: 10.3109/03009742.2015.1127412. Epub 2016 Jan 26.
• Background Valenzuela A, Song P, Chung L. Calcinosis in scleroderma. Curr Opin Rheumatol. 2018 Nov;30(6):554-561. doi: 10.1097/BOR.0000000000000539.
• Background Gorrepati PL, Smith GP. Treatments for calcinosis cutis in autoimmune connective tissue diseases. J Am Acad Dermatol. 2022 Nov;87(5):1211-1212. doi: 10.1016/j.jaad.2022.03.029. Epub 2022 Mar 22. No abstract available.
• Background Nigwekar SU. Multidisciplinary approach to calcific uremic arteriolopathy. Curr Opin Nephrol Hypertens. 2015 Nov;24(6):531-7. doi: 10.1097/MNH.0000000000000175.
• Background Bair B, Fivenson D. A novel treatment for ulcerative calcinosis cutis. J Drugs Dermatol. 2011 Sep;10(9):1042-4.
• Background Goossens J, Courbebaisse M, Caudron E, Bahans C, Vacquerie V, Melchior J, Salle PV, Moesch C, Daudon M, Frocht V, Richette P, Ea HK, Guigonis V. Efficacy of intralesional sodium thiosulfate injections for disabling tumoral calcinosis: Two cases. Semin Arthritis Rheum. 2017 Dec;47(3):451-455. doi: 10.1016/j.semarthrit.2017.05.013. Epub 2017 Jun 17.
• Background Baumgartner-Nielsen J, Olesen AB. Treatment of Skin Calcifications with Intra-lesional Injection of Sodium Thiosulphate: A Case Series. Acta Derm Venereol. 2016 Feb;96(2):257-8. doi: 10.2340/00015555-2206. No abstract available.
• Background Song P, Fett NM, Lin J, Merola JF, Costner M, Vleugels RA. Lack of response to intravenous sodium thiosulfate in three cases of extensive connective tissue disease-associated calcinosis cutis. Br J Dermatol. 2018 Jun;178(6):1412-1415. doi: 10.1111/bjd.15783. Epub 2018 Mar 7.
• Background Mageau A, Guigonis V, Ratzimbasafy V, Bardin T, Richette P, Urena P, Ea HK. Intravenous sodium thiosulfate for treating tumoral calcinosis associated with systemic disorders: Report of four cases. Joint Bone Spine. 2017 May;84(3):341-344. doi: 10.1016/j.jbspin.2016.10.009. Epub 2016 Dec 7.
• Background Del Barrio-Diaz P, Moll-Manzur C, Alvarez-Veliz S, Vera-Kellet C. Topical sodium metabisulfite for the treatment of calcinosis cutis: a promising new therapy. Br J Dermatol. 2016 Sep;175(3):608-11. doi: 10.1111/bjd.14412. Epub 2016 Apr 17.
• Background Patra S, Gupta V, Kumar R, Verma KK. Clinical and radiological improvement in idiopathic calcinosis cutis with topical 25% sodium metabisulfite. Int J Dermatol. 2017 Dec;56(12):1464-1465. doi: 10.1111/ijd.13789. Epub 2017 Oct 26. No abstract available.
• Background Chung L, Valenzuela A, Fiorentino D, Stevens K, Li S, Harris J, Hutchinson C, Assassi S, Beretta L, Lakshminarayanan S, Rodriguez-Reyna TS, Denton CP, Taillefer RG, Herrick AL, Baron M; Scleroderma Clinical Trials Consortium Calcinosis Working Group. Validation of a novel radiographic scoring system for calcinosis affecting the hands of patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2015 Mar;67(3):425-30. doi: 10.1002/acr.22434.
• Background Valenzuela A, Stevens K, Chung MP, Rodriguez-Reyna TS, Proudman S, Baron M, Castelino FV, Hsu V, Green L, Galdo FD, Li S, Fiorentino D, Chung L. Change in calcinosis over 1 year using the scleroderma clinical trials consortium radiologic scoring system for calcinosis of the hands in patients with systemic sclerosis. Semin Arthritis Rheum. 2022 Apr;53:151980. doi: 10.1016/j.semarthrit.2022.151980. Epub 2022 Feb 10.
• Background Gamissans M, Giavedoni P, Roe E, Sanchez J, Quintana-Codina M, Garbayo-Salmons P, Vidal D, Riera-Marti N, Lopez-Llunell C, Romani J, Wortsman X. Multicentric Study on High-Frequency Ultrasound Characterization of Calcium Deposits in Dermal and Subcutaneous Calciphylaxis and Calcinosis. J Ultrasound Med. 2022 Aug;41(8):1975-1979. doi: 10.1002/jum.15878. Epub 2021 Nov 10.

Drugs

Indications