Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis
Condition: Calcinosis
MeSH terms: Dermatomyositis; Calcinosis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Five individuals who meet the eligibility criteria will take part in this study. They will
      have a variety of assessments performed throughout the treatment period in order to evaluate
      both dermatomyositis and calcinosis severity and their potential response to fractional
      carbon dioxide and sodium thiosulfate treatment. A medical history will be taken and baseline
      assessments will be performed during the screening period. Serum creatinine kinase levels
      will be determined on this visit and repeated at the end of the study (week 20); these levels
      will be one measure of monitoring disease activity during the study. One calcinosis lesion
      will be treated, assessed, and followed. If a second calcinosis lesion is present, it will
      act as a control (not treated). Two weeks prior to the first treatment session, an optional
      (not required) skin biopsy of the target (treated) calcinosis lesion will be offered to the
      the first 3 patients ≥ 18 years of age to determine optimal fractional carbon dioxide laser
      settings that will be used for treatment. Area and durometer (a device that measures
      hardness) measurements and photographs of the calcinosis lesions will be performed at weeks
      0,4,8,12,16,and 20. One x-ray of the control and one x-ray of the target calcinosis lesion
      will also be performed during the screening period and at week 20. Assessment of muscle
      strength, physical functioning, endurance, and range of motion, as well as myositis activity
      outside of the muscles will be performed during the screening period and at weeks 8 and 20.
      Myositis damage assessment will be performed at the screening period and at week 20.
      Questionnaires to assess physical functioning pertaining to activities of daily living and
      quality of life, as well as the quality of life related to skin disease and the calcinosis
      lesions will be completed during the screening period and at weeks 8 and 20. Treatment of the
      target calcinosis lesion with fractional carbon dioxide laser and topical sodium thiosulfate
      will occur on weeks 0,2,4,6,8,10,12,14,16,and 18. Each patient will receive a total of 8-10
      treatments over a 6 month period. Assessments for any side effects from the treatment will be
      performed prior to each treatment session on weeks 0,2,4,6,8,10,12,14,16,18, and 20.
    

Intervention name(s): Fractionated Carbon Dioxide (FCO2) Laser; Sodium thiosulfate
Intervention type(s): Device; Drug
Intervention description(s): 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.
Other intervention name(s): Candela QuadraLase (TM)
Intervention MeSH terms: Sodium thiosulfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dermatomyositis; Superficial calcinosis; Fractional carbon dioxide laser; Sodium thiosulfate