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OpenTrials
Completed

NCT Number: NCT00740285

Effectiveness and Safety of Lidocaine for Scleroderma

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.

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Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Limited Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universidade Federal de São Paulo

São Paulo, 04039-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine 2% without vessel constrictor

Drug
  • 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 - physiological solution 0,9%

Other

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

Primary outcomes

  1. Skin thickening evaluated by Skin Score

    Time frame: before, immediately after the intervention and 6 months later

Secondary outcomes

  1. Safety - evaluated by the adverse effects during the intervention

    Time frame: immediately after the intervention

  2. Quality of Life evaluated by HAQ

    Time frame: before, immediately after the intervention and 6 months later

  3. Pressure at lower esophagus evaluated by esophagus manometry

    Time frame: before, immediately after the intervention and 6 months later

  4. Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy

    Time frame: before, immediately after the intervention and 6 months later

  5. Subjective evaluation by patients

    Time frame: before, immediately after the intervention and 6 months later

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Aug 22, 2008
Registry last updated
Aug 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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