A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis
Status:
Withdrawn
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Calcinosis cutis refers to a group of disorders characterized by calcium deposition in the
skin (1). The disorders are classified according to etiology into the following types:
dystrophic, metastatic, iatrogenic, and idiopathic (1,2). Dystrophic calcification occurs in
the setting of varicosities, infection, tumors, and connective tissue disorders (1). The
connective tissue disorders most commonly associated with calcinosis cutis are systemic
sclerosis and dermatomyositis, although it has also been reported in patients with systemic
lupus erythematosus, undifferentiated connective tissue disorder, and mixed connective tissue
disorder (2). The pathophysiology of calcinosis cutis is not well understood, and there is a
broad range of severity seen, from benign localized, small nodules to large, severely
debilitating lesions (2). Although many therapies have been investigated for treatment of
calcinosis cutis, including calcium channel blockers, colchicine, minocycline, intravenous
immunoglobulin, and bisphosphonates, results have been mixed at best (2). Surgical removal is
sometimes feasible in the case of a localized lesion, however, recurrence after surgery is
common (2).
Recently, several authors have reported cases of dramatic resolution of dystrophic calcinosis
cutis lesions with topical sodium thiosulfate preparations (1,3,4). Systemic sodium
thiosulfate therapy is commonly used to treat calciphylaxis in patients with renal disorders
with very few adverse events (1). A search of the literature to date yields no formal studies
that aim to determine whether topical sodium thiosulfate is truly an effective therapy for
calcinosis cutis. As a result, patients are often treated with therapies that are unproven or
ineffective and their calcinosis cutis eventually leads to significant pain and disability.
Research Question:
Does treatment of dystrophic calcinosis cutis with topical sodium thiosulfate result in
diminution of the lesion and associated pain?
Objective:
The objective of this pilot study is to investigate whether topical sodium thiosulfate is an
effective therapy for calcinosis cutis. This study will also determine the feasibility of our
protocol and provide information to help direct a future full-scale trial.