Effectiveness and Safety of Lidocaine for Scleroderma

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Glucuronyl glucosamine glycan sulfate; Lidocaine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Scleroderma (diffuse or limited) at less than 5 years of the first symptom

Exclusion Criteria:

• Overlap with other connective tissue diseases

• Fibromyalgia

• Pregnancy

• Current use of ciclofosfamide ou D-penicillamine