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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Submitted, not yet approved
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
In vivo assessment of triple agent thermo-responsive otic gels in patients with acute otitis externa. Phase 2 trial.
Scientific title
In vivo assessment of triple agent thermo-responsive otic gels in patients with acute otitis externa. Phase 2 trial.
Secondary ID [1] 296605 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Externa 310413 0
Condition category
Condition code
Ear 309127 309127 0 0
Other ear disorders
Infection 309215 309215 0 0
Other infectious diseases

Study type
Description of intervention(s) / exposure
The patient will receive a single dose of 0.5ml of the thermoresponsive gel containing active ingredients ciprofloxacin 0.6% and dexamethasone 0.2%. This will be delivered by blunt needle and syringe to the ear canal. Patient review/follow up will occur on day 2, if no improvement is seen patients will be removed from the study and given alternative treatment. Further review will occur on day 5 and 12 review of patient symptoms, side effects and ear will occur to ensure patient safety. If the gel remains visible in the external auditory canal at day 12 review, aural toilet will be performed to remove any of the remaining gel. Patients will be contacted four weeks following cessation of treatment to ensure no recurrence or side effects have occurred.
Intervention code [1] 312913 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group

Primary outcome [1] 308109 0
Time to resolution - absence of any symptoms of OE as described by patient
Timepoint [1] 308109 0
Endpoint of 2/52 post initial treatment
Primary outcome [2] 308110 0
? Clinical cure - yes vs no

Cure - defined as an absence of any signs or symptoms of OE including inflammation, pain or tenderness and discharge.
Failure to Cure - defined as the presence of any signs or symptoms of OE including inflammation, pain or tenderness and discharge.

Signs: As assessed under microscopy in the ENT Outpatient department.
Symptoms: As assessed on a study-specific VAS 10-scale questionnaire.
Timepoint [2] 308110 0
Endpoint of 2/52 post initial treatment
Secondary outcome [1] 353977 0
Microbiological resolution - Yes or No
Timepoint [1] 353977 0
Microbiological Swab conducted at start of treatment and at 2/52 post commencement of treatment.
Yes - Swab - normal skin flora / no microbes
No - Swab with microbial growth other then those listed above.
Secondary outcome [2] 353978 0
Rate of recurrence
Timepoint [2] 353978 0
Participant Reported - Assessed by phone call to patient at 4/52 post completion of treatment.
Secondary outcome [3] 353979 0
Potential side effects - irritation, burning or stinging, infection, TM perforation
Timepoint [3] 353979 0
Participant reported and on clinical review at Follow up 4/52 post treatment.

Key inclusion criteria
o Aged between 18-60 years at time of recruitment
o ASA 1-28 (healthy, non-smoker or with mild disease without substantive functional limitations)
o Available for ongoing follow up and review
Minimum age
18 Years
Maximum age
60 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
o Overt fungal otitis externa based on clinical examination
o Congenital abnormality, obstructive exostoses or malignancy of the ear canal
o Seborrheic dermatitis or other dermatological conditions of the affected external ear canal.
o Known or suspected tympanic membrane perforation or tympanostomy tube
o Known allergy or sensitivity to ciprofloxacin, quinolones, dexamethasone, corticosteroids or shell fish.
o Patients who have an ASA 3 or more (severe systemic disease)8
o Patients who are pregnant or lactating

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis
This trials aim is to assess efficacy of the thermo-responsive gel in OE and monitoring for adverse events. Therefore, given our small sample size, we will not be monitoring for size of effect.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 12409 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 24676 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301184 0
Name [1] 301184 0
University of Queensland
Address [1] 301184 0
Saint Lucia, QLD 4072
Country [1] 301184 0
Primary sponsor type
University of Queensland
Saint Lucia, QLD 4072
Secondary sponsor category [1] 300806 0
Name [1] 300806 0
Address [1] 300806 0
Country [1] 300806 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301924 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 301924 0
199 Ipswich Rd, Woolloongabba QLD 4102
Ethics committee country [1] 301924 0
Date submitted for ethics approval [1] 301924 0
Approval date [1] 301924 0
Ethics approval number [1] 301924 0

Brief summary
Otitis Externa (swimmers ear) is inflammation of the ear canal and leads to significant pain. The current treatment involves ear drops which are difficult to insert and requiring regular insertion. This leads to decreased patient compliance and a notably increasing level of antimicrobial resistance.

This project involves the initial assessment of a newly created thermoresponsive ear gel (a gel that is drops at room temperature and changes to a gel a body temperature) in individuals with otitis externa. We hypothesis the ear gel will gelate in the ear canal, treating otitis externa and causing minimal adverse events.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 88578 0
Dr Jemma Porrett
Address 88578 0
The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 88578 0
Phone 88578 0
+61 07 31762111
Fax 88578 0
Email 88578 0
Contact person for public queries
Name 88579 0
Dr Jemma Porrett
Address 88579 0
The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 88579 0
Phone 88579 0
+61 07 31762111
Fax 88579 0
Email 88579 0
Contact person for scientific queries
Name 88580 0
Dr Jemma Porrett
Address 88580 0
The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 88580 0
Phone 88580 0
+61 07 31762111
Fax 88580 0
Email 88580 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results