Effectiveness and Safety of Lidocaine for Scleroderma

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00740285
First received: August 19, 2008
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Scleroderma
Drug: Lidocaine 2% without vessel constrictor
Other: Placebo - physiological solution 0,9%
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Skin thickening evaluated by Skin Score [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety - evaluated by the adverse effects during the intervention [ Time Frame: immediately after the intervention ] [ Designated as safety issue: Yes ]
  • Quality of Life evaluated by HAQ [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
  • Pressure at lower esophagus evaluated by esophagus manometry [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
  • Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
  • Subjective evaluation by patients [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2004
Study Completion Date: April 2007
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740285

Locations
Brazil
Universidade Federal de São Paulo
São Paulo, Brazil, 04039-001
Sponsors and Collaborators
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
  More Information

Publications:
1. Atra E, Goldenberg J, Sasso WS. Proposição de um novo tratamento para esclerodermia utilizando o cloridrato de dietilamino 2,6 dimetilacetanilida. Revista Brasileira de Reumatologia 1977;maio/jun: 75-80. 2. Flickman PH, Jefrey JJ, Eifen V. Asensivity micritol Sd.ay for prolin hidroxilase activity in normal psoriatic skin. Jounal of Investigate tecnology 1973;60 (46). 3. White B, the ACR Comittee on Study Design and Response Parameters in SSc: Guidelines for clinical trials with disease-modifying intervention in systemic sclerosis (SSc). Arthritis Rheum 1993; 36 (suppl): S131 4. Jimenes AS, Hitraya E, Varga J. Pathogenesis of scleroderma: Collagen. In: Rheumatic Diseases Clinics of North America - Scleroderma 1996. 22(4):647 .

ClinicalTrials.gov Identifier: NCT00740285     History of Changes
Other Study ID Numbers: 390/00
Study First Received: August 19, 2008
Last Updated: August 21, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
scleroderma
scleroderma - limited or diffuse types
lidocaine
effectiveness

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Pharmaceutical Solutions
Lidocaine
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014