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

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

Patrocinadores

Patrocinador principal: Loyola University

Fuente Loyola University
Resumen breve

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.

Estado general Withdrawn
Fecha de inicio September 2013
Fecha de Terminación September 2013
Fecha de finalización primaria September 2013
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in calcinosis cutis lesion size from week 0 to week 12 for the experimental arm versus placebo arm After 12 weeks of treatment
Resultado secundario
Medida Periodo de tiempo
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
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Sodium thiosulfate

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

Etiqueta de grupo de brazo: Sodium Thiosulfate

Tipo de intervención: Drug

Nombre de intervención: Placebo

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

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Fecha de verificación

November 2016

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Loyola University

Nombre completo del investigador: Elaine Adams

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Sodium Thiosulfate

Tipo: Experimental

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

Etiqueta: Placebo

Tipo: Placebo Comparator

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

Acrónimo STS-CALC
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov