Clinical trial NCT00740285: Effectiveness and Safety of Lidocaine for Scleroderma
Official title: Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Scleroderma
Keywords: scleroderma
scleroderma - limited or diffuse types
lidocaine
effectiveness
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-08-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Skin thickening evaluated by Skin Score
timeFrame: before, immediately after the intervention and 6 months later
Secondary outcomes:
measure: Safety - evaluated by the adverse effects during the intervention
timeFrame: immediately after the intervention
measure: Quality of Life evaluated by HAQ
timeFrame: before, immediately after the intervention and 6 months later
measure: Pressure at lower esophagus evaluated by esophagus manometry
timeFrame: before, immediately after the intervention and 6 months later
measure: Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy
timeFrame: before, immediately after the intervention and 6 months later
measure: Subjective evaluation by patients
timeFrame: before, immediately after the intervention and 6 months later
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rachel Riera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de São Paulo
name: Virginia FM Trevisani, PhD
role: STUDY_CHAIR
affiliation: Universidade Federal de São Paulo
name: Alexandre WS Silva, PhD
role: STUDY_DIRECTOR
References:
citation: 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.