Phase 2
N=6
Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis
Calcinosis
Bottom Line
View on ClinicalTrials.gov: NCT01572844 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales. — -38.0; 3.3; -53.1; 2.0 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fractionated Carbon Dioxide (FCO2) Laser (Device); Sodium thiosulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alison Ehrlich
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales. |
-38.0; 3.3; -53.1; 2.0 | — |
| SECONDARY Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Hardness as Measured by a Difference in Durometer (Rex Durometer Model 1600, Type OO) Measurements. |
-35.8; -18.4; 7.4; 23.8 | — |
| SECONDARY Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales. |
104.7; 136.5; 0; 1.9 | — |
| SECONDARY Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies. |
0; 0 | — |
| SECONDARY Change in Patient Functionality and/or Quality of Life. |
-37.5; 57.1; -44.4; 0; 3.4; -6.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01572844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.