Scleroderma Clinical Trial
Official title:
Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial
Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally
classified as one of the autoimmune rheumatic diseases. The disease is characterized by
thickening and fibrosis skin, affecting vessels and many organs such as the esophagus,
stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still
unknown, but scientists and medical investigators in a wide variety of fields are working
hard to make those determinations. It is known that scleroderma involves overproduction of
collagen.
FLICKMAN et al, in 1973 published an article about the role of lidocaine at
prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production.
Until now, there is only a case series showing the improvement of thickening skin (75%) and
esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a
RCT to prove these findings.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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