Presentation Description
Institution: RBWH - Queensland , Australia
Botulinum toxin type A is a neurotoxic protein produced from the Clostridium botulinum bacteria. Botulinum toxin was first approved for use in 1989, since there has been a surge in its uses. The latest trend is the unapproved use of botulinum toxin for allergic / non-allergic rhinitis, advertised in cosmetic clinics as “Haytox”.
Aims:
To test the hypothesis that botulinum toxin type A is an effective treatment for rhinitis when delivered via intranasal spray, as measured by total nasal symptom score (TNSS).
Methodology:
A single group open-label non-randomised phase 1 clinical trial was completed. Rhinitis and non-allergic rhinitis were confirmed via formalised testing, with total IgE and RAST testing.
Each participant received a dose of 40 units Botulinum toxin type A administered topically intranasally, 20 units per nostril, using the LMA® MAD Nasal™ Intranasal Mucosal Atomization Device.
Safety of the intervention was assessed with adverse event tracking logs. Symptom scores were used to assess symptom reduction, including TNSS, visual analogue scale (VAS) and peak nasal inspiratory (PNIF) measurements, at weeks 0, 2, 4 and 12. In addition, participants global impression of change (PGIC) was recorded at weeks 4 and 12.
Results:
15 participants received the botulinum toxin treatment, with no serious adverse events or related adverse events were reported.
TNSS and VAS consistently reduced across the cohort from weeks 0 to 12. No significant difference in PNIF scores between weeks 0 and 4 were observed. Whilst the PGIC at week 12 showed 5 participants noticed a difference, 5 noticed no change and 1 participant’s symptoms worsened.
Conclusion:
In this phase 1 trial topical application of botulinum toxin via spray was shown to be safe, without any adverse events. It effectively reduced the TNSS and VAS across the cohort, but there was no significant improvement in PNIF and the PGIC was inconclusive.
Speakers
Authors
Authors
Dr James Bates - , Dr Joshua Liaw - , Ms Alecia Banks - , Ms Kathryn Girling - , Dr James Earnshaw - , Dr Abigail Walker -