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

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ClinicalTrials.gov Identifier: NCT01918904
Recruitment Status : Withdrawn (PI decided not to proceed with this project. No participants were enrolled.)
First Posted : August 8, 2013
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Elaine Adams, Loyola University

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.


Condition or disease Intervention/treatment Phase
Calcinosis Cutis Drug: Sodium thiosulfate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis (STS-CALC)
Study Start Date : September 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium Thiosulfate
A small amount of 25% topical sodium thiosulfate cream twice daily (bid)
Drug: Sodium thiosulfate
A small amount of 25% topical sodium thiosulfate cream twice daily (bid)

Placebo Comparator: Placebo
A small amount of topical zinc oxide and aquaphor cream twice daily (bid)
Drug: Placebo
A small amount of topical zinc oxide and aquaphor cream twice daily (bid)




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918904


Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Elaine Adams, M.D. Loyola University
Study Director: Melissa R Bussey, M.D. Loyola University
Publications:
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Responsible Party: Elaine Adams, Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01918904    
Other Study ID Numbers: 205683
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Keywords provided by Elaine Adams, Loyola University:
calcinosis
sodium thiosulfate
topical treatment
connective tissue disease
Additional relevant MeSH terms:
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Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Sodium thiosulfate
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents