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Botulinum Toxin in Burning Mouth Syndrome

NCT02964728 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-12-07

No results posted yet for this study

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.

Conditions

  • Burning Mouth Syndrome

Interventions

DRUG

Botulinum Neurotoxin Type A

topical injection

OTHER

Normal saline

topical injection

Sponsors & Collaborators

  • Carlo Besta Neurological Institute

    collaborator OTHER

  • University of Catania

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • Presidio Ospedaliero Garibaldi-Centro

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-05-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964728 on ClinicalTrials.gov