In vivo assessment of triple agent thermo-responsive otic gels in patients with acute otitis externa. Phase 2 trial.

Phase 2

• Conditions: Otitis Externa; Ear - Other ear disorders; Infection - Other infectious diseases

• Registration Number: ACTRN12618001896268
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-21
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

oAged between 18-60 years at time of recruitment
oASA 1-28 (healthy, non-smoker or with mild disease without substantive functional limitations)
oAvailable for ongoing follow up and review

Exclusion Criteria

oOvert fungal otitis externa based on clinical examination
oCongenital abnormality, obstructive exostoses or malignancy of the ear canal
oSeborrheic dermatitis or other dermatological conditions of the affected external ear canal.
oKnown or suspected tympanic membrane perforation or tympanostomy tube
oKnown allergy or sensitivity to ciprofloxacin, quinolones, dexamethasone, corticosteroids or shell fish.
oPatients who have an ASA 3 or more (severe systemic disease)8
oPatients who are pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to resolution - absence of any symptoms of OE as described by patient[Endpoint of 2/52 post initial treatment ]; ? Clinical cure - yes vs no <br><br>Cure - defined as an absence of any signs or symptoms of OE including inflammation, pain or tenderness and discharge. <br>Failure to Cure - defined as the presence of any signs or symptoms of OE including inflammation, pain or tenderness and discharge. <br><br>Signs: As assessed under microscopy in the ENT Outpatient department. <br>Symptoms: As assessed on a study-specific VAS 10-scale questionnaire. <br>[Endpoint of 2/52 post initial treatment ]

Secondary Outcome Measures

Name	Time	Method
Rate of recurrence[Participant Reported - Assessed by phone call to patient at 4/52 post completion of treatment. ];Potential side effects - irritation, burning or stinging, infection, TM perforation [Participant reported and on clinical review at Follow up 4/52 post treatment. ];Microbiological resolution - Yes or No [Microbiological Swab conducted at start of treatment and at 2/52 post commencement of treatment. <br> Yes - Swab - normal skin flora / no microbes <br> No - Swab with microbial growth other then those listed above. ]