A Phase 2/3 interventional study of Lidocaine 2% without vessel constrictor and Placebo - physiological solution 0,9% in Scleroderma, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-08-22.
Sponsored by Federal University of São Paulo · Phase 2/3, Interventional, and Treatment
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.
534 studies on the registry are indexed under Scleroderma, Diffuse; 115 are open to participants now.
This study's enrollment of 26 is below the median of 33 across 371 interventional studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →Federal University of São Paulo is the lead sponsor of 438 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Drug: Lidocaine 2% without vessel constrictor
Other: Placebo - physiological solution 0,9%
* first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours * next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
first 5 days: 20ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours next 5 days: 30ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
Skin thickening evaluated by Skin Score
Time frame: before, immediately after the intervention and 6 months later
Safety - evaluated by the adverse effects during the intervention
Time frame: immediately after the intervention
Quality of Life evaluated by HAQ
Time frame: before, immediately after the intervention and 6 months later
Pressure at lower esophagus evaluated by esophagus manometry
Time frame: before, immediately after the intervention and 6 months later
Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy
Time frame: before, immediately after the intervention and 6 months later
Subjective evaluation by patients
Time frame: before, immediately after the intervention and 6 months later
The record gives a start of Apr 2004, a primary completion of Apr 2006 and a completion of Apr 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Federal University of São Paulo →