An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

NCT ID: NCT04453124

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2019-11-25

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.

Conditions

Yaws; Cutaneous; Cutaneous Ulcer; Yaws

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Soap and Water

Standard of care using soap and water

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ficus Septica Sap

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

Group Type: EXPERIMENTAL

Topical antiseptic treatment

Intervention Type: BIOLOGICAL

Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.

Chlorhexidine (Topical)

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

Group Type: ACTIVE_COMPARATOR

Topical antiseptic treatment

Intervention Type: BIOLOGICAL

Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.

Interventions

Topical antiseptic treatment

Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Papua New Guinea

UNKNOWN

Sponsor Role: collaborator

The Royal Botanic Gardens, Kew

UNKNOWN

Sponsor Role: collaborator

Oriol Mitja

OTHER

Sponsor Role: lead

Responsible Party

Oriol Mitja

Dr. Oriol Mitja

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Lihir Medical Centre

Londolovit, New Ireland Province, Papua New Guinea

University of Papua New Guinea

Port Moresby, , Papua New Guinea

Countries

Papua New Guinea

Other Identifiers

SAPKOKOPO

Identifier Type: -

Identifier Source: org_study_id