drugset / Trial / NCT00740285

Effectiveness and Safety of Lidocaine for Scleroderma

NCT00740285

Phase 2/3 Completed 26 enrolled Federal University of São Paulo
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2004-04
Primary completion
2006-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 30 ml Intravenous

Indications