Topical Carica Papaya Ointment Trial for wound healing
- Conditions
- superficial skin wound healingSkin - Normal skin development and function
- Registration Number
- ACTRN12621000561886
- Lead Sponsor
- ucas' Papaw Remedies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Change in Cumulative Irritation Score (CIS) from baseline (day 1) to end of study (day 10)[Assessed daily during the treatment phase, from Day 1 to Day 10 of study]
- Secondary Outcome Measures
Name Time Method 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).[Difference between score at Day 1 and Day 10, Assessed at Day 10];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.[Assessed at Day 5 and Day 10];Cosmetic outcome of ointment treated patch – assessed by treating Health Care Professional (HCP) on VAS from 0 (poor) to 10.[Assessed at Day 11, end of study visit];Time to disappearance of erythema, using the erythema scale EASI scoring (0-4). Assessed from Photographs.[Assessed daily during the treatment phase, from Day 1 to Day 10 of study];Subject rated Itch scale (0-10 VAS).[Assessed daily during the treatment phase, from Day 1 to Day 10 of the study]