Scleroderma
Conditions
Keywords
scleroderma, scleroderma - limited or diffuse types, lidocaine, effectiveness
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.
Interventions
* first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours * next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
OTHERPlacebo - 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
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin thickening evaluated by Skin Score | before, immediately after the intervention and 6 months later |
Secondary
| Measure | 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 |
| 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 |
Countries
Brazil
Outcome results
None listed