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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.
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

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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.

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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
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
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/12/2018
Actual
Date of last participant enrolment
Anticipated
29/03/2019
Actual
Date of last data collection
Anticipated
29/04/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
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
University
Name [1] 301184 0
University of Queensland
Country [1] 301184 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Saint Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 300806 0
None
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
Ethics committee country [1] 301924 0
Australia
Date submitted for ethics approval [1] 301924 0
05/11/2018
Approval date [1] 301924 0
Ethics approval number [1] 301924 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.