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Trial registered on ANZCTR


Registration number
ACTRN12621000561886
Ethics application status
Approved
Date submitted
17/03/2021
Date registered
12/05/2021
Date last updated
4/02/2022
Date data sharing statement initially provided
12/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Carica Papaya Ointment Trial for wound healing
Scientific title
A single centre, open label, within-subject, controlled study of healthy volunteers to investigate the efficacy of Lucas' Papaw Ointment (topical 4% Carica papaya fruit ointment) in wound healing.
Secondary ID [1] 303725 0
nil known
Universal Trial Number (UTN)
U1111-1266-2380
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
superficial skin wound healing 321156 0
Condition category
Condition code
Skin 318955 318955 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a healthy volunteer study. The volar forearms of each participant are to be wiped with water and soap to remove any sebaceous lipids or contaminants on the skin surface. The participant is to extend both forearms over a workbench with the volar forearm facing upwards.
Tape stripping is to be conducted on both forearms. Tape stripping is repeated on the skin at the same place until the first signs of uniform glistening (superficial wound) on both arms. This should be achieved with approximately 15 tape strips. Treatment ointment is self administered by the study participant to the left arm only, three times per day for 10 consecutive days. The first application of the treatment will occur on the same day as the wound creation, after the photos have been taken. Adherence to the intervention will be checked by a online diary via a Study-specific App that participants will download during their first visit. At the end of each day the Study-specific App will ask the participant to confirm if the ointment has been applied 3 times each day and the participant will document if the treatment has been applied.
The Study-specific App will also be used to collect daily photos of each wound site. The study participants will be asked to take 2 photos each day of each wound site during the 10 day treatment phase of the study. One set of photos is to be taken in outside light and the other in indoors with artificial light. Photos should be taken around the same time each day during daylight hours, just prior to treatment application so that there is no (or little) product on the treatment area when the photos are taken. The photos are uploaded for assessment via the Study-specific App.
Intervention code [1] 320034 0
Treatment: Other
Comparator / control treatment
This study has within subject control. a wound will be created on both forearms of each study participant. The wound on the left arm of each participant will be treated 3 times per day with topical Carica Papaya ointment for 10 consecutive days while the the wound on the right arm of each participant will be untreated as a within subject control.
Control group
Active

Outcomes
Primary outcome [1] 326881 0
Mean Change in Cumulative Irritation Score (CIS) from baseline (day 1) to end of study (day 10)
Timepoint [1] 326881 0
Assessed daily during the treatment phase, from Day 1 to Day 10 of study
Secondary outcome [1] 394038 0
Mean subject Rating of Overall Wound Condition on day 1 vs end of study (day 10), completed via Subject data app (0=minimal severity, 10=maximal severity).
Timepoint [1] 394038 0
Difference between score at Day 1 and Day 10, Assessed at Day 10
Secondary outcome [2] 394039 0
Subject satisfaction of local tolerability of the ointment, using a 5-point Vas and completed via subject data app on day 5 and day 10.
Timepoint [2] 394039 0
Assessed at Day 5 and Day 10
Secondary outcome [3] 394040 0
Cosmetic outcome of ointment treated patch – assessed by treating Health Care Professional (HCP) on VAS from 0 (poor) to 10.
Timepoint [3] 394040 0
Assessed at Day 11, end of study visit
Secondary outcome [4] 394041 0
Time to disappearance of erythema, using the erythema scale EASI scoring (0-4). Assessed from Photographs.
Timepoint [4] 394041 0
Assessed daily during the treatment phase, from Day 1 to Day 10 of study
Secondary outcome [5] 394042 0
Subject rated Itch scale (0-10 VAS).
Timepoint [5] 394042 0
Assessed daily during the treatment phase, from Day 1 to Day 10 of the study

Eligibility
Key inclusion criteria
1. Subjects 18-50 years of age, of any race or ethnicity, in generally good health.
2. Not known to be sensitive or allergic to any of the study emollients or their constituents.
3. Provide a signed and dated informed consent form prior to start of any study-related procedures.
4. Able to comprehend and follow the requirements of the study.
5. Females of childbearing potential, confirmation verbally that they are not pregnant at Screening/Baseline visit.
6. In the case of a female of childbearing potential, is using one acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom, abstinence, partner’s vasectomy, tubal ligation). Females must have used the same birth control for at least one month prior to starting the study and must continue to use this throughout the duration of the study.
7. Willing and able to comply with the tape stripping method.
8. Fitzpatrick score of 1-3.
9. Subject must have a smartphone with a functioning camera.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Females who are pregnant or breastfeeding.
2. Known sensitivity or allergies to the investigational products.
3. Tattoos located on the surface of one or both inner (volar) region of forearms.
4. Heavily pigmented subjects who could heal with abnormal darkening at the test sites on the inner forearms.
5. Subjects who do not have a Fitzpatrick score of 1-3.
6. Presence of excessive hair on the inner forearms which could interfere with the test procedures.
7. Presents with skin disorders on the inner arms (cuts, scratches, scars, etc), which in the opinion of the Investigator or qualified designee, will interfere with the study assessment or will create undue risk for the subject.
8. Pre-existing or dormant dermatologic skin conditions (e.g., eczema, seborrheic dermatitis, atopic dermatitis, psoriasis, vitiligo, etc.) that could interfere with the outcome of the study as determined by the Investigator or qualified designee.
9. Subjects with known chronic inflammatory skin conditions
10. Subjects with keloid scars or tendency to form keloid scars.
11. Subjects with any genodermatosis.
12. Subjects who received any vaccines within 14 days prior to enrolment
13. Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
14. Subjects that are taking regular systemic anti-inflammatory (e.g. NSAIDs, corticosteroids), antiallergic (e.g. antihistamines), anti-infective (e.g. antibiotics, antivirals, antifungal), retinoid (e.g. acitretin), anticoagulant (e.g. warfarin, clopidogrel), analgesics (except for paracetamol) and immunosuppressant (e.g. methotrexate, cyclosporin) medications. Individuals on medications such as analgesics, antihistamines and anti-infectives can be enrolled if medication is stopped at least 48h prior to enrolment.
15. Subjects on regular high dose (single ingredient) products containing fish oil (including vegetable based omega 3 fatty acids), echinacea, Palmitoylethanolamide (PEA), curcumin, bromelain, quercetin, propolis, zinc, oral Vitamin A, E and infusions of any vitamins, unless this is stopped 30 days prior to enrollment. Individuals on other herbal medicines, nutritional supplements, vitamins and minerals are also excluded if they have started the products less than 30 days ago.

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)
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
Other
Other design features
Within subject control, participants will have two wounds created and only one will be treated with the test product and the other will be left untreated as a within subject control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of 31 subjects has been determined on the basis of comparing the hypothesised mean change in PWAT scores from Day 0 to Day 10. With 31 subjects there is 80% power to detect a mean of paired differences in PWAT score of 3 units (SD = 5.7 units] from Day 0 to Day 10 using a two-tailed 5% level of significance. To allow for an attrition rate of 10% from discontinuations and dropouts, the number of subjects is established as 35 subjects.

* For the wound healing (PWAT) sample size calculation
PWAT ranges from 0-32
If comparing mean PWAT scores at Day 0 and Day 10 this becomes a paired t-test (within-subjects design) and can work out the sample size using the one-sample test with a mean null value of 0 and the other value being the difference. The SD should be the SD of the differences.
To work out the standard deviation of the difference, use the variance sum law:
http://onlinestatbook.com/2/glossary/variance_sum_law.html
set scheme clean plots.
Assuming a difference of 10 (e.g. reduction from 20 to 10 on the PWAT) and a SD of differences of 5.7(SD pre-mean = post-mean = 4, SD diffs = sqrt (16 + 16))

+---------------------------------------------------------+
| alpha power N delta m0 ma sd |
|---------------------------------------------------------|
| .05 .8 257 .1754 0 1 5.7 |
| .05 .8 66 .3509 0 2 5.7 |
| .05 .8 31 .5263 0 3 5.7 |
| .05 .8 18 .7018 0 4 5.7 |
| .05 .8 13 .8772 0 5 5.7 |
| .05 .8 10 1.053 0 6 5.7 |
| .05 .8 8 1.228 0 7 5.7 |
| .05 .8 7 1.404 0 8 5.7 |
| .05 .8 6 1.579 0 9 5.7 |
| .05 .8 5 1.754 0 10 5.7 |
+---------------------------------------------------------+

Demographic and baseline characteristics will be summarised for the overall study population. Primary and secondary outcome data will be stratified and summarised by time (baseline and end-of-study) and treatment group (wound only and ointment treated). Continuous data will be reported using descriptive statistics (number of values [n], mean, standard deviation [SD], median, minimum [min] and maximum [max]. Categorical data will be reported using frequency tables (frequencies and percentages). Graphical plots will be presented to augment the tabulated results as appropriate. For inferential tests of hypotheses, a two-tailed p-value <0.05 (type I error rate of 0.05) will determine statistical significance; the confidence level for confidence intervals will be correspondingly set at 95%. No adjustments for multiple comparisons or multiplicity will be made given the exploratory nature of this work.
All participants with at least baseline application of the study medication will be included for analysis, with every effort made to minimise missing data. We anticipate that rates of missing data for reasons other than failure to complete follow-ups will be low, and therefore no imputation procedures will be applied. Accordingly, analyses will be performed using a linear mixed-effects modelling approach to mitigate the effects of missing data, where present, in terms of default listwise deletion procedures. Missing data will be assumed to have an ignorable mechanism (missing completely at random or missing at random).
Summary statistics will be provided for all adverse events (AE’s), and study discontinuation due to AEs during the treatment period. Counts and proportions of participants experiencing AEs will be reported where appropriate. A pre-specified interim analysis will not be conducted. All analyses will be performed using R version 4.0 or higher, using Mac operating system.
Statistics in entirety for this study will be conducted by Avion Medical.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/06/2021
Actual
23/07/2021
Date of last participant enrolment
Anticipated
13/09/2021
Actual
15/09/2021
Date of last data collection
Anticipated
30/09/2021
Actual
27/09/2021
Sample size
Target
33
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18940 0
Griffith University Clinical Trials Unit - Southport
Recruitment postcode(s) [1] 33447 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 308133 0
Commercial sector/Industry
Name [1] 308133 0
Lucas' Papaw Remedies
Country [1] 308133 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lucas' Papaw Remedies
Address
15 Durbell St, Acacia Ridge QLD 4110
Country
Australia
Secondary sponsor category [1] 308894 0
None
Name [1] 308894 0
Address [1] 308894 0
Country [1] 308894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308120 0
Bellberry Limited
Ethics committee address [1] 308120 0
Ethics committee country [1] 308120 0
Australia
Date submitted for ethics approval [1] 308120 0
12/04/2021
Approval date [1] 308120 0
30/06/2021
Ethics approval number [1] 308120 0

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

Contacts
Principal investigator
Name 109606 0
Dr Sachin D Deshmukh
Address 109606 0
Griffith - Clinical Trial Unit
G40 Building, Room 4.60, Gold Coast Campus, Griffith University
Cnr Parklands Drive and Olsen Avenue, Southport, QLD, 4222
Country 109606 0
Australia
Phone 109606 0
+61 07 5678 0929
Fax 109606 0
Email 109606 0
clinicaltrialunit@griffith.edu.au
Contact person for public queries
Name 109607 0
Ari Dearnley
Address 109607 0
Molecule 2 Market
Ground Floor, 35 Cotham Road,
Kew, VIC, 3101
Country 109607 0
Australia
Phone 109607 0
+61 0409 746 142
Fax 109607 0
Email 109607 0
ari@molecule2.com.au
Contact person for scientific queries
Name 109608 0
Sam Vohra
Address 109608 0
Avion Medical
10 Oxley Road,
Hawthorn, VIC, 3122
Country 109608 0
Australia
Phone 109608 0
+61 450 556 969
Fax 109608 0
Email 109608 0
sam@avionmedical.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All individual participant data will be de-identified and only de-identified pooled data will be made publicly available.


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.