Clinical Trial: Botulinum Toxin in Burning Mouth Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Botulinum Toxin in Burning Mouth Syndrome

Brief Summary: 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.

Detailed Summary:
Sponsor: Presidio Ospedaliero Garibaldi-Centro

Current Primary Outcome: 0-100 mm Visual Analog Scale (VAS) improvement [ Time Frame: 1 month ]

Original Primary Outcome: VAS improvement [ Time Frame: 1 month ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Presidio Ospedaliero Garibaldi-Centro

Dates:
Date Received: November 12, 2016
Date Started: November 2015
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016