Effectiveness and Safety of Lidocaine for Scleroderma
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ClinicalTrials.gov Identifier: NCT00740285 |
Recruitment Status :
Completed
First Posted : August 22, 2008
Last Update Posted : August 22, 2008
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Scleroderma | Drug: Lidocaine 2% without vessel constrictor Other: Placebo - physiological solution 0,9% | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | April 2006 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Lidocaine 2% without vessel constrictor
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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 |
- Skin thickening evaluated by Skin Score [ Time Frame: before, immediately after the intervention and 6 months later ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740285
Brazil | |
Universidade Federal de São Paulo | |
São Paulo, Brazil, 04039-001 |
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 |
ClinicalTrials.gov Identifier: | NCT00740285 |
Other Study ID Numbers: |
390/00 |
First Posted: | August 22, 2008 Key Record Dates |
Last Update Posted: | August 22, 2008 |
Last Verified: | August 2008 |
scleroderma scleroderma - limited or diffuse types lidocaine effectiveness |
Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Connective Tissue Diseases Skin Diseases Lidocaine 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 |