Effectiveness and Safety of Lidocaine for Scleroderma

Phase 2

Completed

• Conditions: Scleroderma
• Interventions: Drug: Lidocaine 2% without vessel constrictor; Other: Placebo - physiological solution 0,9%

• Registration Number: NCT00740285
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-04
• Study Completion: 2007-04
• Status Verified: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-21
• Last Update Submitted: 2008-08-21
• Study First Posted: 2008-08-22
• Last Update Posted: 2008-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lidocaine 2% without vessel constrictor	-
2	Placebo - physiological solution 0,9%	-

Primary Outcome Measures

Name	Time	Method
Skin thickening evaluated by Skin Score	before, immediately after the intervention and 6 months later

Secondary Outcome Measures

Name	Time	Method
Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy	before, immediately after the intervention and 6 months later
Quality of Life evaluated by HAQ	before, immediately after the intervention and 6 months later
Pressure at lower esophagus evaluated by esophagus manometry	before, immediately after the intervention and 6 months later
Subjective evaluation by patients	before, immediately after the intervention and 6 months later
Safety - evaluated by the adverse effects during the intervention	immediately after the intervention

Trial Locations

Locations (1)

Universidade Federal de São Paulo; 🇧🇷 São Paulo, Brazil