None listed
Conditions
Brief summary
The aim of this clinical trial is to determine if Lucas papaw ointment assists in wound healing. Lucas papaw ointment was developed in Australia in 1906 and has been used as a topical treatment since this time. The effectiveness of Lucas papaw ointment for wound healing has not been assessed in a clinical trial. This clinical trial aims to clinically assess if Lucas papaw ointment assists with wound healing. A small wound will be created on each arm of the participants, and the Lucas papaw ointment applied to only one arm. The response on each arm will be compared using a photographic assessment tool, participant rating tools and physician assessment tools to assess the wound healing on each arm.
Interventions
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 approxi
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.
Sponsors
Lucas' Papaw Remedies
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed