Clinical Trial: A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis (STS-CALC)

Brief 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:

Detailed Summary:
Sponsor: Loyola University

Current Primary Outcome: Change in calcinosis cutis lesion size from week 0 to week 12 for the experimental arm versus placebo arm [ Time Frame: After 12 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in pain from week 0 to week 12 for the experimental arm versus placebo arm [ Time Frame: After 12 weeks of treatment ]
  (1) Full Scale Name: 100mm Visual Analog Pain Scale (VAS). (2) Definition: The VAS is a pain scale. (3) Construct measured: Pain. (4) VAS Score Range: Raw scores may range from 0 to 10, where higher scores indicate worsening pain. (5) Change Calculation Details: Ordinal measure comparing pain from Baseline (week 0) to Week 12 for the experimental versus placebo arm
• Change in pain from week 0 to week 24 for the experimental arm versus placebo arm [ Time Frame: After 24 weeks of treatment ]
  (1) Full Scale Name: 100mm Visual Analog Pain Scale (VAS). (2) Definition: The VAS is a pain scale. (3) Construct measured: Pain. (4) VAS Score Range: Raw scores may range from 0 to 10, where higher scores indicate worsening pain. (5) Change Calculation Details: Ordinal measure comparing pain from Baseline (week 0) to Week 24 for the experimental versus placebo arm
• Change in calcinosis cutis lesion size from week 0 to week 24 for the experimental arm versus placebo arm [ Time Frame: After 24 weeks of treatment ]
  Definition: Calcinosis cutis lesion. Change Calculation Details: The lesion size will be evaluated at week 0 and again at week 24. Continuous measurement of the lesion in millimeters (mm), where a decrease in diameter indicates improvement.

Original Secondary Outcome: Same as current

Information By: Loyola University

Dates:
Date Received: August 6, 2013
Date Started: September 2013
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016