None listed
Conditions
Brief summary
The aim of this clinical trial is to determine if the study ointment assists with skin conditions including mild eczema and/or rash, cracked or dry skin on heels, insect bites and sunburn. The study ointment is currently in use in Australia as a topical treatment. The effectiveness of the study ointment for skin conditions has not been assessed in a clinical trial. The study team will identify a treatment patch and a similar patch that will not be treated and will be the control site. You will be asked to apply the study ointment 3 times per day to the treatment patch and not to the control patch. Participants with mild eczema and/or rash and cracked or dry skin on heels will be treated with the ointment for 21 consecutive days. Participants with insect bites and sunburn will be treated with the ointment for 10 consecutive days. The response will be assessed using daily photos that will be assessed by the study team using a skin irritation score as well as by a participant rating tool.
Interventions
A diverse population of subjects with existing skin conditions (mild eczema and/or rash, cracked or dry skin on heels, insect bite, sunburn) will present themselves to the trial sites. Subjects will be asked to attend the trial site on day one of the study and the last day of the study. It is possible for subjects to conduct their end of study visit via Telehealth.
Clinical baseline screening will occur on day one of the study and the first treatment of 4% carica papaya fruit ointment will be a
A diverse population of subjects with existing skin conditions (mild eczema and/or rash, cracked or dry skin on heels, insect bite, sunburn) will present themselves to the trial sites. Subjects will be asked to attend the trial site on day one of the study and the last day of the study. It is possible for subjects to conduct their end of study visit via Telehealth. Clinical baseline screening will occur on day one of the study and the first treatment of 4% carica papaya fruit ointment will be applied. The 4% carica papaya fruit ointment will be applied three times per day. All subjects will have a treatment site and untreated site identified at screening determined by the PI. Evaluation of dermal reactions at the two sites will be assess clinically using a visual scale that rates the degree of erythema and other signs of cutaneous irritation. Day one subjects will be assigned into a study cohort, trained to apply a measured amount of trial ointment to the treatment site of their skin condition, and trained to use the data collection app. Trial specific containers of 4% carica papaya fruit ointment, dosage spatulas, instruction leaflets, and a phone app for recording results will be supplied to the subjects. The subject will take two photos of the treated site and two photos of the untreated site every day of the study (one in natural light and one indoors with artificial light). These photos will be taken via the trial app on the patient’s phone and sent directly to the PI for evaluation. Photos are to be taken during daylight hours and just prior to treatment so that there is no (or little) product on the treatment site when the photos are taken. Subjects will record their treatment application via the study app. They will also record the change in irritation and tolerability of 4% carica papaya fruit ointment via the study app. Subjects in Cohort A (Mild eczema and/or rash), and subjects in Cohort B (cracked or dry skin on heels) will apply treatment and record observations for 21 days. Subjects in Cohort C (Insect bites), and subjects in Cohort D (Sunburns) will apply treatment and record observations for 10 days.
Sponsors
Lucas' Papaw Remedies
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Subjects 18-50 years of age, of any race or ethnicity. 1. Not known to be sensitive or allergic to any of the study emollients or their constituents. 2. Provide a signed and dated informed consent form prior to start of any study-related procedures. 3. Able to comprehend and follow the requirements of the study. 4. Females of childbearing potential must have a negative pregnancy test at the Screening/Baseline visit. 5. 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 6. Subjects suffering from one of the conditions as follows (all definitions are to be interpreted by the treating clinician and/or PI for the study site, as appropriate for the study). Can be self-diagnosed and confirmed by the site PI/study nurse at screening visit. Skin conditions can be present prior to start of study (preexisting). Based on clinical judgement of trial site subject should have active: a. Mild eczema and/or rash b. Cracked or dry skin on heels c. Insect bite d. Sunburn 7. Fitzpatrick score 1-3 8. Subject must have a smartphone with a functioning camera.
Exclusion criteria
1. Any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction. 2. Excessive solar damage. 3. Tattoos in the test patches. 4. Known allergic reactions to study components. 5. Pregnancy or lactation. 6. Using systemic/topical corticosteroids within 2 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study. Asthma puffers accepted. 7. History of (last 12 months) or are currently being treated for skin cancer and/or hepatitis. Cancer treatment older than 12 months is acceptable. 8. History of, or is currently being treated for, insulin dependent diabetes. 9. Any condition that might compromise study results. 10. Currently participating in any other clinical testing. 11. Has received any investigational drug(s) within 4 weeks prior to study entry. 12. Subjects that have used Papaw ointment on the treatment selected area, in the last 10 days. 13. Subjects with known allergies to fragrance and/or perfumes
Outcome results
None listed