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

Information source: Loyola University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Calcinosis Cutis

Intervention: Sodium thiosulfate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Loyola University

Official(s) and/or principal investigator(s):
Elaine Adams, M.D., Principal Investigator, Affiliation: Loyola University
Melissa R Bussey, M.D., Study Director, Affiliation: Loyola University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in calcinosis cutis lesion size from week 0 to week 12 for the experimental arm versus placebo arm

Secondary outcome:

Change in pain from week 0 to week 12 for the experimental arm versus placebo arm

Change in pain from week 0 to week 24 for the experimental arm versus placebo arm

Change in calcinosis cutis lesion size from week 0 to week 24 for the experimental arm versus placebo arm

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients seen by the Division of Rheumatology at Loyola Outpatient Center in Maywood,

Illinois (IL), Oak Brook Terrace Outpatient Center in Oakbrook, IL, and Burr Ridge Outpatient Center in Burr Ridge, IL.

- Male and female patients 18 years old and above

- Patients with at least 2 distinct calcinosis cutis lesions separated by at least 10

inches, that are a minimum of 2 millimeters (mm) in diameter, and identifiable on physical exam and ultrasound, such that one lesion may be used as an internal control lesion

- Patients on calcium channel blockers, bisphosphonates, prednisone, and colchicine

will be included Exclusion Criteria:

- Patients with calcinosis cutis lesions that appear actively infected (i. e.,

exhibiting purulent drainage and malodor) will not be included

- Patient with concomitant use of systemic intravenous sodium thiosulfate for treatment

of calciphylaxis will not be included

- Patients with hypercalcemia will not be included

- Patients who are pregnant or breastfeeding will not be included

- Patients who are allergic to sulfa and/or zinc will not be included

Locations and Contacts

Additional Information

Related publications:

Bair B, Fivenson D. A novel treatment for ulcerative calcinosis cutis. J Drugs Dermatol. 2011 Sep;10(9):1042-4.

Gutierrez A Jr, Wetter DA. Calcinosis cutis in autoimmune connective tissue diseases. Dermatol Ther. 2012 Mar-Apr;25(2):195-206. doi: 10.1111/j.1529-8019.2012.01492.x. Review.

Ratsimbazafy V, Bahans C, Guigonis V. Dramatic diminution of a large calcification treated with topical sodium thiosulfate. Arthritis Rheum. 2012 Nov;64(11):3826. doi: 10.1002/art.34628.

Wolf EK, Smidt AC, Laumann AE. Topical sodium thiosulfate therapy for leg ulcers with dystrophic calcification. Arch Dermatol. 2008 Dec;144(12):1560-2. doi: 10.1001/archderm.144.12.1560.

Starting date: September 2013
Last updated: November 19, 2013

Page last updated: August 20, 2015

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