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

NCT ID: NCT01918904

Last Updated: 2016-11-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-09-30

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:

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.

Conditions

Calcinosis Cutis

Keywords

calcinosis; sodium thiosulfate; topical treatment; connective tissue disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sodium Thiosulfate

A small amount of 25% topical sodium thiosulfate cream twice daily (bid)

Group Type: EXPERIMENTAL

Sodium thiosulfate

Intervention Type: DRUG

A small amount of 25% topical sodium thiosulfate cream twice daily (bid)

Placebo

A small amount of topical zinc oxide and aquaphor cream twice daily (bid)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A small amount of topical zinc oxide and aquaphor cream twice daily (bid)

Interventions

Sodium thiosulfate

A small amount of 25% topical sodium thiosulfate cream twice daily (bid)

Intervention Type: DRUG

Placebo

A small amount of topical zinc oxide and aquaphor cream twice daily (bid)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Elaine Adams

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Adams, M.D.

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Melissa R Bussey, M.D.

Role: STUDY_DIRECTOR

Loyola University

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 22052275 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22741938 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 22806424 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 19075137 (View on PubMed)

Other Identifiers

205683

Identifier Type: -

Identifier Source: org_study_id