asal solgel therapy performance in healthy volunteers

Phase 1

• Conditions: chronic rhinosinusitis; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12620000318987
• Lead Sponsor: Angelica Lynch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-09
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

i.Aged between 18-50
ii.Currently fit and healthy
iii.Available for required follow up

Exclusion Criteria

i.Sinonasal disease requiring intranasal or systemic medications
ii.Require more than one tissue per day to blow the nose
iii.Daily use of any steroid medication
iv.Allergies to any of the medications being used: dexamethasone, lignocaine or phenylephrine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if and how long the solgel remains on the nasal mucosa in vivo[5 minutes post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz) ];To determine whether the solgel is readily removed with cold saline washes[5 minutes post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz)]

Secondary Outcome Measures

Name	Time	Method
Potential local side effects of the gels including: nasal obstruction, irritation, burning, taste or smell and postnasal drip or rhinorrhoea. This will be assessed using a study-specific questionnaire[2-4 hours; 6-8 hours; day 2; day 5; day 8 and day 12 post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz). 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.]