Effectiveness and Safety of Lidocaine for Scleroderma

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial

Conditions
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Scleroderma

Intervention / Treatment
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* Drug: Lidocaine 2% without vessel constrictor
* Other: Placebo - physiological solution 0,9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Lidocaine 2% without vessel constrictor<br>* 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<br>|
| Placebo Comparator: 2<br> | Other: Placebo - physiological solution 0,9%<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin thickening evaluated by Skin Score |  | before, immediately after the intervention and 6 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - evaluated by the adverse effects during the intervention |  | immediately after the intervention | 
| 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 | 
| Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy |  | before, immediately after the intervention and 6 months later | 
| Subjective evaluation by patients |  | before, immediately after the intervention and 6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, scleroderma, scleroderma - limited or diffuse types, effectiveness