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The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
Sponsor: Oticara Australia PTY LTD
Summary
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2023-08-17
Completion Date
2025-06-01
Last Updated
2024-11-12
Healthy Volunteers
No
Conditions
Interventions
Betamethasone Dipropionate Nasal Cream 0.0644%
Betamethasone Dipropionate Nasal Cream 0.0644% is applied topically to the inflamed tissue of the sinus using a pre-filled syringe and applicator under the guidance of an endoscope. Up to 5g on each side of the sinus (10g in total).
Pre-filled syringe and applicator device
Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.
Locations (4)
Oticara Investigational Site
Sydney, New South Wales, Australia
Oticara Investigational Site
Brisbane, Queensland, Australia
Oticara Investigational Site
Adelaide, South Australia, Australia
Oticara Investigational Site
Perth, Western Australia, Australia