A Phase 2 interventional study of Topical antiseptic treatment in Yaws; Cutaneous, Cutaneous Ulcer and Yaws, sponsored by Oriol Mitja. Completed at 2 sites in Papua New Guinea. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Oriol Mitja · Phase 2, Interventional, and Treatment
In a search for accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identify the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro.
This is an open label clinical trial using an interventional approach, to compare the effect of the antiseptic plant sap and standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.
The cutaneous ulcer is a painful and debilitating bacterial infection that is common in rural areas of Papua New Guinea (PNG). Systematic treatment with topical antiseptics such as chlorhexidine cream in theory represents a viable treatment option, but in reality, effective treatment of cutaneous ulcers in Papua New Guinea is greatly hindered by the remote and highly inaccessible areas that affected communities often live in. In a search for more accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identified the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro. The sap displays comparable activity to chlorhexidine in disc diffusion assays with gram-positive bacterial wound pathogens. It also appears to dampen the pro-inflammatory responses of neutrophils by down regulating interleukin-6 expression. The sap forms a flexible plastic-like wound covering which may help deter flies from feeding on the wounds, and unlike chlorhexidine cream, the Ficus tree is easy to find where affected communities live. For this reason, this study aims to perform an open label clinical trial using an interventional approach, to compare the effect of this antiseptic plant sap and of a standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.
79 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
This study's enrollment of 150 is above the median of 44 across 65 interventional studies indexed under Skin Ulcer.
Browse Skin Ulcer studies →Oriol Mitja is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Inclusion Criteria:
-children aged 5 to 15 with parental consent and with one or more skin breaks of any nature (i.e. Skin cuts, scratch, scrapes or abrasion and mosquito bites) that are less than 1cm in major diameter. Written informed consent by parent or guardian will be required before enrolment.
Exclusion Criteria::
Standard of care using soap and water
Ficus Septica Sap, topical cream, 50ul, daily, for 2 days
Biological: Topical antiseptic treatment
Chlorhexidine, topical solution, 50ul, daily, for 2 days
Biological: Topical antiseptic treatment
Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.
Number of participants with Clinical Healing in each arm
surface reduction by more than 50%
Time frame: 21 days
Number of participants with Clinical Healing in each arm
Ulcer healing determined by a professional dermatologist, described as as: appearance of granulation tissue, healed borders, dry ulcer, no exudation.
Time frame: 21 days
Changes in wound microbiology
Up to five key pathogens identified by next generation sequencing of wound fluids will be quantified at Day 0 and at Day 21 for samples from each arm of the study
Time frame: 21 days
Plan to share: Yes — All individual variables will be available through direct contact with corresponding author
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Oriol Mitja