An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

Yaws Clinical Trial

Official title:

An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453124
• Other study ID #: SAPKOKOPO
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: September 2020
• Source: Lihir Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 25, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Ulcer
• Skin Ulcer
• Ulcer
• Yaws
• Yaws; Cutaneous

Intervention

Biological:
• Topical antiseptic treatment
Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.

Locations

Country	Name	City	State
Papua New Guinea	Lihir Medical Centre	Londolovit	New Ireland Province
Papua New Guinea	University of Papua New Guinea	Port Moresby

Sponsors (3)

Lead Sponsor	Collaborator
Oriol Mitja	The Royal Botanic Gardens, Kew, The University of Papua New Guinea

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Clinical Healing in each arm	surface reduction by more than 50%	21 days
Primary	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	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