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Trial registered on ANZCTR
Registration number
ACTRN12618001896268p
Ethics application status
Submitted, not yet approved
Date submitted
14/11/2018
Date registered
21/11/2018
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
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.
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Scientific title
In vivo assessment of triple agent thermo-responsive otic gels in patients with acute otitis externa. Phase 2 trial.
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Secondary ID [1]
296605
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Otitis Externa
310413
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Condition category
Condition code
Ear
309127
309127
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0
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Other ear disorders
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Infection
309215
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
312913
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Time to resolution - absence of any symptoms of OE as described by patient
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Assessment method [1]
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Timepoint [1]
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Endpoint of 2/52 post initial treatment
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Primary outcome [2]
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? 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.
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Assessment method [2]
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Timepoint [2]
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Endpoint of 2/52 post initial treatment
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Secondary outcome [1]
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Microbiological resolution - Yes or No
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Assessment method [1]
353977
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Timepoint [1]
353977
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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.
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Secondary outcome [2]
353978
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Rate of recurrence
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Assessment method [2]
353978
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Timepoint [2]
353978
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Participant Reported - Assessed by phone call to patient at 4/52 post completion of treatment.
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Secondary outcome [3]
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Potential side effects - irritation, burning or stinging, infection, TM perforation
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Assessment method [3]
353979
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Timepoint [3]
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Participant reported and on clinical review at Follow up 4/52 post treatment.
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Eligibility
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
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
17/12/2018
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Actual
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Date of last participant enrolment
Anticipated
29/03/2019
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Actual
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Date of last data collection
Anticipated
29/04/2019
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
24676
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Queensland
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Address [1]
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Saint Lucia, QLD 4072
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Country [1]
301184
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Australia
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Primary sponsor type
University
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Name
University of Queensland
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Address
Saint Lucia, QLD 4072
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Country
Australia
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Secondary sponsor category [1]
300806
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None
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Name [1]
300806
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Address [1]
300806
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Country [1]
300806
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
301924
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
301924
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199 Ipswich Rd, Woolloongabba QLD 4102
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Ethics committee country [1]
301924
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Australia
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Date submitted for ethics approval [1]
301924
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05/11/2018
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Approval date [1]
301924
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Ethics approval number [1]
301924
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jemma Porrett
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Address
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The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 07 31762111
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Jemma Porrett
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Address
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The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 07 31762111
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Jemma Porrett
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Address
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The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 07 31762111
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Fax
88580
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Email
88580
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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