Clinical trial NCT04453124: An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
Official title: An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Yaws; Cutaneous
Cutaneous Ulcer
Yaws
Lead sponsor: Lihir Medical Centre
Sponsor class: OTHER
Collaborators: name: The University of Papua New Guinea
name: The Royal Botanic Gardens, Kew
First posted: 2020-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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::

* All participants who have received medical treatment for skin ulcers up to 2 months prior to recruitment (azithromycin, amoxicillin, benzathine penicillin, etc.).
* Patients who require antibiotic treatment for another condition not-related to the study.
* Known history of hypersensitivity, allergic or adverse reaction to the study product.
* Patients presenting cutaneous ulcer more than 1cm

Primary outcomes:
measure: Number of participants with Clinical Healing in each arm
timeFrame: 21 days
measure: Number of participants with Clinical Healing in each arm
timeFrame: 21 days
Secondary outcomes:
measure: Changes in wound microbiology
timeFrame: 21 days
Other outcomes:
Locations:
city: Londolovit
country: Papua New Guinea
facility: Lihir Medical Centre
state: New Ireland Province
city: Port Moresby
country: Papua New Guinea
facility: University of Papua New Guinea
Study officials:
References: