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Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream

NCT05220293 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-05-02

No results posted yet for this study

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).

Conditions

  • Chronic Rhinosinusitis (Diagnosis)

Interventions

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.

Sponsors & Collaborators

  • Oticara Australia PTY LTD

    lead INDUSTRY

Principal Investigators

  • Oticara Clinical · Oticara Australia PTY LTD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2023-12-30
Completion
2023-12-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220293 on ClinicalTrials.gov