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

NCT01918904 | Withdrawn Phase 2

• 1 other identifier: 205683
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  Definition: Calcinosis cutis lesion. Change Calculation Details: The lesion size will be evaluated at week 0 and again at week 12. Continuous measurement of the lesion in millimeters (mm), where a decrease in diameter indicates improvement.

  After 12 weeks of treatment

Secondary Outcomes (3)

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

  After 12 weeks of treatment

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

  After 24 weeks of treatment

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

  After 24 weeks of treatment

Study Arms (2)

Sodium Thiosulfate

EXPERIMENTAL

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

Drug: Sodium thiosulfate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sodium thiosulfate DRUG

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

Sodium Thiosulfate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Related Publications (4)

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

  PMID: 22052275 BACKGROUND

• 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.

  PMID: 22741938 BACKGROUND

• 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.

  PMID: 22806424 BACKGROUND

• 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.

  PMID: 19075137 BACKGROUND

MeSH Terms

Conditions

Calcinosis Cutis; Calcinosis; Connective Tissue Diseases

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elaine Adams, M.D.

  Loyola University

  PRINCIPAL INVESTIGATOR

• Melissa R Bussey, M.D.

  Loyola University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 8, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 17, 2016

Record last verified: 2016-11