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RECRUITING
NCT05882903
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DEVICE

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