NCT05882903

The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Oticara Australia PTY LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.

Detailed description

In this open-label study, a single dose of the corticosteroid Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) will be administered under endoscopic guidance to the sinus mucosa of post-FESS patients whose chronic rhinosinusitis (CRS) condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and endoscopic assessment of the sinus mucosa.

Conditions

• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-05-31
• Last updated: 2024-11-12

Locations

4 sites across 1 country: Australia