The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4
patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds
of the tongue and the lower lip for at least 6 months, refractory to common pharmacological
treatments. Pain severity will be measured by the visual analog scale (VAS) indicating
average week pain before injection. Each patient will be injected with a total dose of 16
units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and
4 units into each antero-lateral side of the tongue. In order to determine if a placebo
effect may be involved, we will inject 2 additional patients with saline solution using the
same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at
4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated
after 4 weeks with incobotulinumA with the same dose reported above.
Phase:
Phase 2
Details
Lead Sponsor:
Presidio Ospedaliero Garibaldi-Centro
Collaborators:
Carlo Besta Neurological Institute University of Catania University of Padova
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA