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Effectiveness and Safety of Lidocaine for Scleroderma
This study has been completed.
Sponsor:
Federal University of São Paulo
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:
Genetics Home Reference related topics:
systemic scleroderma
MedlinePlus related topics:
Scleroderma
U.S. FDA Resources
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 ]
Secondary Outcome Measures:
- Safety - evaluated by the adverse effects during the intervention [ Time Frame: immediately after the intervention ]
- Quality of Life evaluated by HAQ [ Time Frame: 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 ]
- Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy [ Time Frame: before, immediately after the intervention and 6 months later ]
- Subjective evaluation by patients [ Time Frame: before, immediately after the intervention and 6 months later ]
| 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
|
| 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00740285
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 |
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 Glucuronyl glucosamine glycan sulfate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents |
Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anticoagulants Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Fibrinolytic Agents Fibrin Modulating Agents Hypoglycemic Agents |
ClinicalTrials.gov processed this record on July 24, 2017