Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis
Condition: Calcinosis
MeSH terms: Dermatomyositis; Calcinosis
Intervention: Fractionated Carbon Dioxide (FCO2) Laser; Sodium thiosulfate
Intervention description: At each treatment visit, a 2 X 2 cm (+/- 1 cm) area of the target calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser. Patients will receive a total of 8-10 treatments over a 6 month period.; Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only. Subjects will receive a total of 8-10 treatments over a 6 month period.
Intervention MeSH terms: Sodium thiosulfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dermatomyositis; Superficial calcinosis; Fractional carbon dioxide laser; Sodium thiosulfate

Summary:

      Dermatomyositis is an inflammatory muscle disorder that is often associated with many skin
      findings. One of the skin findings seen in up to 50% of individuals with juvenile
      dermatomyositis, an early onset form of this condition, and up to 20-30% of adult
      dermatomyositis patients who have not responded to treatment, is calcinosis, or deposits of
      calcium within the skin and muscle tissue. In addition to being cosmetically unappealing,
      involvement of deeper tissues with calcinosis may lead to contractures, or shortening of
      muscles, which may have a significant impact on functioning and quality of life.
      Unfortunately, there is no known effective treatment of dermatomyositis associated
      calcinosis. However, recent reports have shown that a medication called sodium thiosulfate
      has been effective in treating individuals with calciphylaxis, a condition where calcium is
      deposited within blood vessels, and with tumoral calcinosis, a genetic form of calcification,
      when receiving this medication by vein. In addition, recent advances in laser technology have
      led to the development of methods that may allow topical medications to penetrate deeper
      layers of the skin. The investigators have designed a pilot study to evaluate the use of
      topical sodium thiosulfate solution in treating superficial calcinosis in individuals with
      juvenile and adult dermatomyositis. The investigators will use laser to assist in the
      delivery of this medication to areas of calcinosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals of both sexes and of all ethnicities who wish to participate in the study
             and who have signed a written informed consent form to participate.

          -  Subjects must be between the ages of 18-65 years.

          -  Subjects must have a diagnosis of adult or juvenile dermatomyositis.

          -  All patient must be on stable therapy for their condition. Overall disease activity
             must be considered mild or in remission.

          -  Patients must have a history of failing at least one therapy for calcinosis associated
             with dermatomyositis.

          -  Patients must have at least one localized area of superficial calcinosis with easily
             identifiable landmarks. Whenever possible, subjects will have a second localized area
             of superficial calcinosis that can serve as a control lesion for repeated assessment.

          -  The calcinosis lesion being treated and the control calcinosis lesion must be stable
             (not increasing in size) based on the patient's history.

          -  Patients must be able to attend all treatment sessions and assessment visits at our
             Washington, District of Columbia clinic over the 20 week period.

        Exclusion Criteria:

          -  Unstable dermatomyositis, or moderate or severely active juvenile dermatomyositis.

          -  Serum creatine kinase greater than or equal to three times the upper limit of normal.

          -  Inability to make study visits or anticipated poor compliance.

          -  Active infections, including a history of recurrent superinfection or cellulitis at
             the sites of calcinosis (> 1 prior episode).

          -  Pregnant females or nursing mothers.

          -  Life threatening illness that would interfere with the patient's ability to complete
             the study.

          -  Known or suspected history of drug or alcohol abuse within the past 6 months.

          -  Participation in another clinical experimental therapeutic study within 30 days of
             screening visit.

          -  History of severe illness or any other condition that would make the patient
             unsuitable for the study.

          -  History of hepatitis B, hepatitis C, HIV, cancer-associated myositis, or an underlying
             malignancy.