NCT05220293

Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Oticara Australia PTY LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single dose, pilot study, to assess the efficacy and safety of Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) for the treatment of eosinophilic Chronic Rhinosinusitis (eCRS).

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 eCRS condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and visualization 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%, up to 5g per sinus.
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: 2022-02-23
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-02-02
• Last updated: 2024-05-02

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study