Effectiveness and Safety of Lidocaine for Scleroderma

August 21, 2008 updated by: Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04039-001
        • Universidade Federal de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety - evaluated by the adverse effects during the intervention
Time Frame: immediately after the intervention
immediately after the intervention
Quality of Life evaluated by HAQ
Time Frame: before, immediately after the intervention and 6 months later
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
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
before, immediately after the intervention and 6 months later
Subjective evaluation by patients
Time Frame: before, immediately after the intervention and 6 months later
before, immediately after the intervention and 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Rachel Riera, MD, Universidade Federal de São Paulo
  • Study Chair: Virginia FM Trevisani, PhD, Universidade Federal de São Paulo
  • Study Director: Alexandre WS Silva, PhD, Universidade Federal de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

August 22, 2008

Last Update Submitted That Met QC Criteria

August 21, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 390/00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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