An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

Oriol Mitja

Status and phase: Completed; Phase 2

Conditions: Yaws; Cutaneous; Yaws; Cutaneous Ulcer

Treatments: Biological: Topical antiseptic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04453124

SAPKOKOPO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Soap and Water

No Intervention group

Description:

Standard of care using soap and water

Ficus Septica Sap

Experimental group

Description:

Ficus Septica Sap, topical cream, 50ul, daily, for 2 days

Treatment:

Biological: Topical antiseptic treatment

Chlorhexidine (Topical)

Active Comparator group

Description:

Chlorhexidine, topical solution, 50ul, daily, for 2 days

Treatment:

Biological: Topical antiseptic treatment