An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Yaws; Yaws; Cutaneous; Cutaneous Ulcer
• Intervention / Treatment: Biological: Topical antiseptic treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Papua New Guinea
  • Port Moresby, Papua New Guinea
    • University of Papua New Guinea
  • New Ireland Province
    • Londolovit, New Ireland Province, Papua New Guinea, 034
      • Lihir Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Soap and Water; Standard of care using soap and water
Experimental: Ficus Septica Sap; Ficus Septica Sap, topical cream, 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.
Active Comparator: Chlorhexidine (Topical); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Clinical Healing in each arm	surface reduction by more than 50%	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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	21 days

Collaborators and Investigators

• Sponsor: Oriol Mitja
• Collaborators: The University of Papua New Guinea; The Royal Botanic Gardens, Kew

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Ulcer; Skin Ulcer; Anti-Infective Agents; Anti-Infective Agents, Local
• Other Study ID Numbers: SAPKOKOPO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All individual variables will be available through direct contact with corresponding author
• IPD Sharing Time Frame: After publication of data for 1 year
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No