Calcinosis Cutis Clinical Trial
Official title:
A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis (STS-CALC)
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
|
Phase 4 | |
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