Trial registered on ANZCTR


Trial ID
ACTRN12613000930785
Ethics application status
Approved
Date submitted
15/08/2013
Date registered
22/08/2013
Date last updated
7/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of Musaceae Musa (banana skin) versus cryotherapy for the treatment of warts in patients in primary care.
Scientific title
Musaceae Musa as a treatment of cutaneous warts (MuTrecut); a clinical trial.
Secondary ID [1] 283016 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MuTreCut
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Warts 289844 0
Condition category
Condition code
Skin 290200 290200 0 0
Dermatological conditions
Alternative and Complementary Medicine 290229 290229 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is raw banana skin cut to the size of the wart and placed under occlusion with a conventional medical occlusive tape for a period of 12 hours, once daily for 2 weeks. This treatment may be extended beyond two weeks or replaced with an alternative treatment (Cryotherapy or salicyclic acid cream) for up to a period of 16 weeks. The participant will be required to take a photograph the wart before application of the banana skin every night.
Intervention code [1] 287731 0
Treatment: Other
Comparator / control treatment
Cryotherapy and or salicyclic acid cream.
The cyrotherapy will involve the direct application of liquid nitrogen to the wart until blanching of the surface of the wart. Treatment will be weekly for 4 weeks. Treatment with cryotherapy will be offered if the participant is randomised to this treatment at recruitment. The wart will be photographed before the application of this treatment. The salicyclic acid treatment will be with over the counter cream following the directions of the manufacturer, usually applied as a thin smear across the wart each day. Treatment with salicyclic acid will follow either banana skin treatment or cyrotherapy if those treatments are unsuccessful. The wart will be photographed before the application of each treatment.
Control group
Active

Outcomes
Primary outcome [1] 290227 0
The clearance of cutaneous warts on digital camera photographs as assessed by an independent healthcare professional (practice nurse) blind to the treatment group at each review
Timepoint [1] 290227 0
At complete clearance of the warts or 16 weeks whichever is sooner.
Secondary outcome [1] 304153 0
Pain intensity (on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable), self-reported by patients and assessed by paper based questionnaires at each follow up period every 2 weeks.
Timepoint [1] 304153 0
Every two weeks review after starting treatment until the completion of the trail at 16 weeks or the wart is clear, whichever is sooner.
Secondary outcome [2] 304154 0
Use of painkillers (number of days painkillers taken), self-reported by patients and assessed on a Likert scale. the likert scale will assess how much pain the participant is experiencing from the treatment on a scale from 0-10. Where 0 = no pain and 10 = worst possible pain.
Timepoint [2] 304154 0
Every two weeks review after starting treatment until the completion of the trail at 16 weeks or the wart is clear, whichever is sooner.
Secondary outcome [3] 304155 0
Patient satisfaction with the treatment (on a scale of 5 point scale, from 'very unhappy' to 'very happy'), self-reported by patients and assessed by paper based questionnaires
Timepoint [3] 304155 0
Every two weeks review after starting treatment until the completion of the trail at 16 weeks or the wart is clear, whichever is sooner.
Secondary outcome [4] 304209 0
Economic Analysis

The primary economic evaluation will be a cost-effectiveness analysis of the trial treatments. The evaluation will be carried out from the perspective of health services, which includes both Medicare and non-Medicare health related costs, over a time horizon of 12 weeks. The cost of resource use will be calculated for each trial participant using the data collected on the number of visits to healthcare professionals in relation to cutaneous wart treatment and cost of other wart treatments purchased by the patient. Staff costs will be calculated using standard Medicare costs .
Topical treatments will be costed using the PBS Formulary and manufacturer's costs where required. Patient outcome will be measured as the primary outcome i.e. complete clearance of all warts at 16 weeks. The incremental mean difference in costs between the two trial arms and incremental difference in patient outcome will be calculated and we will calculate an incremental cost effectiveness ratio of cost per patient cured at 16 weeks. If cryotherapy is less costly than banana skin treatment and more effective or if cryotherapy is more costly but less effective, then one treatment clearly dominates the other and there is a clear choice about the treatment that is cost-effective. If non-dominance occurs we must weigh up the potential cost implications versus patient benefit to make a decision regarding cost-effectiveness. We will do this by relating the incremental mean costs between the two trial arms to the incremental mean outcome as a ratio, the incremental cost-effectiveness ratio (ICER). The ICER represents the additional cost per additional patient cured. Uncertainty regarding the cost-effectiveness analysis will be assessed using cost-effectiveness acceptability curves.
Timepoint [4] 304209 0
At completion of the trial at 16 weeks.

Eligibility
Key inclusion criteria
People attending Ocean Key's family practice (OKFP), Clarkson; Currambine Family Practice and Murray Medical Centre in Western Australia with cutaneous warts on their feet or hands will be invited.

All participants will be 8 years and older. Those below 18 years of age will be required to provide parental consent
Minimum age
8 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No participant with an allergy to bananas will be eligible to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
People attending Ocean Key's family practice (OKCP), Clarkson; Currambine Family Practice and Murray Medical Centre in Western Australia for cutaneous warts on their feet or hands will be invited. All participants will 8 years of age or older, those below 18 years of age will also be required to provide parental consent. The interested participants will give informed consent.

Total of 112 participants will be enrolled in the study and randomized using computer generated random numbers and distributed into two arms with 56 participants in each arm:

Arm 1: A trial of banana skin treatment
Arm 2: Immediate cryotherapy using liquid Nitrogen

Allocation will be concealed by central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will be randomized using a randomization table created by computer software (i.e. computer sequence generation). The randomization will be performed using a permuted random blocking strategy, so that the numbers will accumulate to each arm of the study at an approximately equal rate.

The total of 112 participants enrolled in the study will be randomized using this computer software into two arms.

Arm 1: Receive Banana skin Treatment
Arm 2: Receive Cryotherapy Treatment

Allocation will be concealed if it was done by central randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical Analysis:

Sample Size-
It is anticipated that 30.5% of warts will be clear as assessed from a photograph by a nurse following treatment with cryotherapy. A clearance of twice that proportion, similarly assessed from a photo by a nurse, would be clinically significant. Therefore a sample of 56 cases for each type of treatment is required to test this hypothesis at 90 % power, 5% significance.

Randomization-
Prior to commencement of the study, a sequence of consecutive study numbers will be generated, and allocated to one treatment (Banana skin) or the other (Cryotherapy) using a computer generated random number. The randomization will be performed using a permuted random blocking strategy, so that the numbers will accumulate to each arm of the study at an approximately equal rate. Varying the block length will make it difficult to anticipate the next treatment before it is allocated. The treatment allocation schedule and study numbers will be kept in a secure place and only be accessible by a person dealing with administrative aspects of the study. The photographs of the warts will be reviewed by a practice nurse blind to the treatment group allocation.

Data Analysis-
We will use simple descriptive statistics to compare the 2 groups (banana vs cryo) at baseline, on the grounds of their demographic and health profile. We will use Chi square statistics or t-tests as appropriate to assess the significance of any difference between groups.
The primary hypothesis (clearance of the verucca at 4 weeks) will be assessed using the Chi-square statistic.
If there do appear to be any differences between groups at baseline, adjustments for these variables will be made by treating them as covariates in a logistic regression model. This model may also identify if the success of treatment is different for subjects with a particular profile (based on gender, age, comorbidities, for example). The analysis will be performed on an Intention to Treat (ITT) basis, where each subject will be classified according to their allocated treatment, regardless of the treatment actually received.
Analysis of the times to clearance will be performed initially using Kaplan-Meier methods. The log-rank test will be used to compare the curves. If adjustment for baseline data is deemed necessary, then a Cox Proportional Hazards model may be used.
Pain killer use and overall satisfaction with treatment will be compared both at the end of the study (using either a non-parametric test or t-test), as well as at all data collection points during the study (using a repeated measures analysis - either a standard ANOVA for repeated measures, or a Friedmann's non-parametric test).
Statistical analyses will be performed using the SPSS statistical software, and a p value < 0.05 will be taken to indicate a statistically significant association.

Economic Analysis-
The primary economic evaluation will be a cost-effectiveness analysis of the trial treatments. The evaluation will be carried out from the perspective of health services, which includes both Medicare and non-Medicare health related costs, over a time horizon of 12 weeks. The cost of resource use will be calculated for each trial participant using the data collected on the number of visits to healthcare professionals in relation to cutaneous wart treatment and cost of other wart treatments purchased by the patient. Staff costs will be calculated using standard Medicare costs.
Topical treatments will be costed using the PBS Formulary and manufacturer's costs where required. Patient outcome will be measured as the primary outcome i.e. complete clearance of treated warts. The incremental mean difference in costs between the two trial arms and incremental difference in patient outcome will be calculated and we will calculate an incremental cost effectiveness ratio of cost per patient cured at 16 weeks. If cryotherapy is less costly than banana skin treatment and more effective or if cryotherapy is more costly but less effective, then one treatment clearly dominated the other and there is clear choice about the treatment that is cost-effective. If non-dominance occurs we must weigh up the potential cost implications versus patient benefit to make a decision regarding cost-effectiveness. We will do this by relating the incremental mean costs between the two trial arms to the incremental mean outcome as a ratio, the incremental cost-effectiveness ratio (ICER). The ICER represents the additional cost per additional patient cured. Uncertainty regarding the cost-effectiveness analysis will be assessed using cost-effectiveness acceptability curves.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7275 0
6030 - Clarkson
Recruitment postcode(s) [2] 7276 0
6210 - Mandurah
Recruitment postcode(s) [3] 7277 0
6028 - Currambine
Recruitment postcode(s) [4] 8698 0
6926 - Kalamunda

Funding & Sponsors
Funding source category [1] 287786 0
University
Name [1] 287786 0
Curtin University.
Address [1] 287786 0
Curtin University, Kent Street, Bentley, Perth, WA 6102
Postal Address: GPO Box U1987, Perth, WA, 6845
Country [1] 287786 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University, Kent Street, Bentley, Perth, WA 6102
Postal Address: GPO Box U1987, Perth, WA, 6845
Country
Australia
Secondary sponsor category [1] 286516 0
None
Name [1] 286516 0
Address [1] 286516 0
Country [1] 286516 0
Other collaborator category [1] 277578 0
Commercial sector/Industry
Name [1] 277578 0
Ocean Keys Family Practice
Address [1] 277578 0
2/5 Ebb Way, Clarkson WA 6030
Country [1] 277578 0
Australia
Other collaborator category [2] 277579 0
Commercial sector/Industry
Name [2] 277579 0
Murray Medical Centre
Address [2] 277579 0
34-36 Minilya Parkway, Mandurah, WA 6210
Country [2] 277579 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289736 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 289736 0
Office of Research and Development,
PO Box U1987, Bentley
Perth WA 6845
Ethics committee country [1] 289736 0
Australia
Date submitted for ethics approval [1] 289736 0
31/07/2013
Approval date [1] 289736 0
16/09/2013
Ethics approval number [1] 289736 0
HR 136/2013

Summary
Brief summary
Most cutaneous warts resolve spontaneously with time. Evidence for the effectiveness of medical treatment is lacking and results of treatment can be frustrating. Consequently, health practitioners view cutaneous warts as a low priority as far as providing treatments, but the adverse effect on the quality of life of some patients with cutaneous warts can be significant. Anecdotal evidence suggests that a 'natural remedy' the skin of bananas (Musaceae Musa) is an effective treatment. In this phase 2 randomized controlled trial the team will test the hypothesis that banana skin treatment can resolve cutaneous warts, in half the time and in twice the proportion of patients as those receiving cryotherapy.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 42142 0
Prof Moyez Jiwa
Address 42142 0
Curtin University- Department of Medical education
GPO Box U1987, Perth WA 6845
Country 42142 0
Australia
Phone 42142 0
+61 8 9266 1768
Fax 42142 0
+61 8 9266 2508
Email 42142 0
m.jiwa@curtin.edu.au
Contact person for public queries
Name 42143 0
Dr Osama Guirguis
Address 42143 0
Murray Medical Centre
34-36 Minilya Parkway, Mandurah, WA 6210
Country 42143 0
Australia
Phone 42143 0
+61 8 9408 5400
Fax 42143 0
Email 42143 0
osguirguis@hotmail.com
Contact person for scientific queries
Name 42144 0
Prof Moyez Jiwa
Address 42144 0
Curtin University- Department of Medical education
GPO Box U1987, Perth WA 6845
Country 42144 0
Australia
Phone 42144 0
+61 8 9266 1768
Fax 42144 0
+61 8 9266 2508
Email 42144 0
m.jiwa@curtin.edu.au