Nasal solgel therapy performance in healthy volunteers

Solgel applied to the nasal cavity mucosa to ascertain its mucoadhesive capabilities. Solgel consists of: - Poloxamer 407 16% w/w - Glycerin 3% w/w - Propylparaben 0.03% w/w - Polyvinyl alcohol 0.03% w/w - Polycarbophil 0.02% w/w - Dexamethasone 21-phosphate sodium salt 0.1% w/w - water soluble blue dye All participants will be provided with a participant information sheet describing the purpose, goals and methods of the trial. The trial will be conducted in the otolaryngology head and neck surgery (OHNS) outpatient clinic at the Princess Alexandra Hospital by both consultant and registrar OHNS surgeons. All participants will lie at 30 degrees on a bed and receive two actuations (100 micrograms/actuation) of Co-phenycaine nasal spray (ENT Technologies, Melbourne) to each nostril to anaesthetise and decongest the nasal cavity prior to administration of solgel. A flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz) will be used to visualise 0.5ml of solgel applied to the lateral nasal wall and middle turbinate. This will be applied to one side of the nasal cavity only. Solgel will be applied manually using syringe + 14G metal suction tip procured from MEDIPLAST Malmö, Sweden. The first component of the trial assesses the reversibility of the solgel. Three participants will have gel applied as above. After five minutes, to ensure gelation of the solgel has occurred, they will rinse the nasal cavity with 200mls of sterile saline water at room temperature using a nasal douching bottle. A nasendoscope will be reinserted to assess the adequacy of the washout with photo documentation. If required, repeated washouts will be undertaken until the gels are unable to be visualised and a recording of the number of washes required will be noted. The second stage involves assessing the duration and potential side effects of the gel. Each participant will have solgel applied in liquid form to their nasal cavity. A photo will be taken immediately following the gels application and again at 2-4 hours and 6-8 hours post application on day 1. Photos will again be taken on days 2 and 5. At this stage, if the participant remains healthy and unaffected by the drug they will be reviewed again on day 8 and 12. At each review we will assess the presence of remaining gel and examine for any evidence of mucosal irritation or erosion. If the gel remains visible at day 12, the participant will rinse out the remaining gel with room temperature sterile saline water using a nasal douching bottle. Participants from stage 1 will not be involved in stage 2. Stage 2 will begin on the same day as stage 1. During the examination, once the gel is deemed to no longer be visible, participants will fill out a questionnaire assessing nasal symptoms associated with the gel including: nasal obstruction, irritation or burning, bleeding, post nasal drip, rhinorrhoea, smell and taste. All images taken throughout will be saved onto the Karl Storz system as a study number and transferred to an encrypted USB. Participants will be asked to avoid rinsing their nose with water and avoid forceful blowing of the nose during the treatment. They will be given details to register any side effects during or after the trial.