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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 2% without vessel constrictor | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin thickening evaluated by Skin Score | before, immediately after the intervention and 6 months later |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - evaluated by the adverse effects during the intervention | immediately after the intervention | |
| Quality of Life evaluated by HAQ | before, immediately after the intervention and 6 months later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Riera, MD | Universidade Federal de São Paulo | Principal Investigator |
| Virginia FM Trevisani, PhD | Universidade Federal de São Paulo | Study Chair |
| Alexandre WS Silva, PhD | Universidade Federal de São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de São Paulo | São Paulo | São Paulo | 04039-001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8923589 | Background | Jimenez SA, Hitraya E, Varga J. Pathogenesis of scleroderma. Collagen. Rheum Dis Clin North Am. 1996 Nov;22(4):647-74. doi: 10.1016/s0889-857x(05)70294-5. |
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| D045745 | Scleroderma, Limited |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| 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 |
|
| Pressure at lower esophagus evaluated by esophagus manometry | before, immediately after the intervention and 6 months later |
| Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy | before, immediately after the intervention and 6 months later |
| Subjective evaluation by patients | before, immediately after the intervention and 6 months later |
| Aniline Compounds |
| D000588 | Amines |