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Trial registered on ANZCTR


Registration number
ACTRN12618001517268p
Ethics application status
Submitted, not yet approved
Date submitted
27/08/2018
Date registered
11/09/2018
Date last updated
11/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The In vivo assessment of a thermoresponsive otic gel in healthy individuals. Phase 1 trial.
Scientific title
The In vivo assessment of a thermoresponsive otic gel in healthy individuals. Phase 1 trial.
Secondary ID [1] 295917 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Externa 309402 0
Condition category
Condition code
Ear 308252 308252 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will involve two stages:
Stage 1: 0.1ml of thermoresponsive gel will be placed onto the right upper back by the principle investigator/medical professional. The average time for the gel to set will be recorded and once set the wound will be covered with an adhesive dressing. The patient will be asked to keep this in place and as dry as possible for 48 hours. After 48 hours the participant will be reviewed and the dressing will be removed in clinics. The underlying skin will be reviewed for signs of reaction. The participants will be reviewed again 7 days post treatment. At this time a questionnaire will be completed and if no adverse reaction or events have occurred and the patient is happy to continue will begin stage 2 of treatment.

Stage 2: - Patients will have pictures taken of there ear canal via a camera inserted into the outer ear canal. Following this they will receive a dose of 0.85ml of thermoresponsive ear gel via syringe and soft cannula to the left ear canal by the principle investigator/medical professional. Further photos will be taken following the thermoresponsive gel application and then at 2-4 hours and 6-8 hours after the gel was initially applied (Day 1). This will be repeated on day 2, 5, 8 and 12 or until the gel is no longer visible. If still present at day 12 - the gel will be removed using aqua ear solution to flush. Patients will be asked to complete a short questionnaire following completion of trial.
Intervention code [1] 312240 0
Treatment: Drugs
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307223 0
Time to gelation
- this will be assessed by tilting of the head and visual
assessment for drug spillage - this will be performed at 1,3 and 5 mins following insertion.
Timepoint [1] 307223 0
5 minutes
Primary outcome [2] 307224 0
Gel retention time
- This will be assessed via visual inspection of the external auditory canal at 2-4 and 6-8 hours post gel insertion as well as day 2, 5, 8 and 12. Retention will be considered if gel remains in the canal. If still present at day 12 - the gel will be removed using aqua ear solution to flush.
Timepoint [2] 307224 0
Day 12 post insertion of gel into the external auditory canal
Secondary outcome [1] 351170 0
Local Side Effects
- Irritation, burning or stinging, infection
tympanic membrane perforation
Assessed on a 10 point visual analogue scale, completed by participants at review on day 12.
Timepoint [1] 351170 0
3 weeks post removal of gel

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?
Yes
Key exclusion criteria
o Patients with infection or irritation of the ear canal
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 Patients who have had their ear canal treated with topical antibiotics, steroids or antifungal within 7 days of presentation
o Use of topical alcohol, vinegar, hydrogen peroxide or other medication to the affected ear leading up to the visit
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 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This trials aim is to assess adequate gelation of the thermo-responsive gel in healthy ear canals 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
1/10/2018
Actual
Date of last participant enrolment
Anticipated
15/10/2018
Actual
Date of last data collection
Anticipated
11/11/2018
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11740 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 23821 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 300514 0
University
Name [1] 300514 0
The University Of Queensland
Country [1] 300514 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Saint Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 299990 0
None
Name [1] 299990 0
Address [1] 299990 0
Country [1] 299990 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301304 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 301304 0
199 Ipswich Rd, Woolloongabba QLD 4102
Ethics committee country [1] 301304 0
Australia
Date submitted for ethics approval [1] 301304 0
16/08/2018
Approval date [1] 301304 0
Ethics approval number [1] 301304 0

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 healthy individuals. We hypothesis the ear gel will gelate in the ear canal causing minimal adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86566 0
Dr Jemma Porrett
Address 86566 0
The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 86566 0
Australia
Phone 86566 0
+61 07 31762111
Fax 86566 0
Email 86566 0
[email protected]
Contact person for public queries
Name 86567 0
Jemma Porrett
Address 86567 0
The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 86567 0
Australia
Phone 86567 0
+61 07 31762111
Fax 86567 0
Email 86567 0
[email protected]
Contact person for scientific queries
Name 86568 0
Jemma Porrett
Address 86568 0
The Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 86568 0
Australia
Phone 86568 0
+61 07 31762111
Fax 86568 0
Email 86568 0
[email protected]

No information has been provided regarding IPD availability


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.