Healthy Volunteers Clinical Trial
Official title:
Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans
Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at
neuronal level. Its activity is express as blocking the axonal conduction, stopping the
propagation of the nerve impulse. The objective of the present work is to evaluate the
neosaxitoxin efficacy and safety as local anesthetic in a human trial
Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The
anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA
Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters:
sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch
perception threshold.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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