Effectiveness and Safety of Lidocaine for Scleroderma

Federal University of São Paulo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Scleroderma

Treatments: Drug: Lidocaine 2% without vessel constrictor; Other: Placebo - physiological solution 0,9%

Study type: Interventional

Funder types: Other

Identifiers

NCT00740285

390/00

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Lidocaine 2% without vessel constrictor

2

Placebo Comparator group

Treatment:

Other: Placebo - physiological solution 0,9%