An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

NCT04453124 | Completed Phase 2

• 1 other identifier: SAPKOKOPO
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Yaws; Cutaneous; Cutaneous Ulcer; Yaws

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in wound microbiology

  21 days

Study Arms (3)

Soap and Water

NO INTERVENTION

Standard of care using soap and water

Ficus Septica Sap

EXPERIMENTAL

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

Biological: Topical antiseptic treatment

Chlorhexidine (Topical)

ACTIVE COMPARATOR

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

Biological: Topical antiseptic treatment

Interventions

Topical antiseptic treatment BIOLOGICAL

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

Chlorhexidine (Topical); Ficus Septica Sap

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oriol Mitja: lead
• The University of Papua New Guinea: collaborator
• The Royal Botanic Gardens, Kew: collaborator

Study Sites (2)

Lihir Medical Centre

Londolovit, New Ireland Province, 034, Papua New Guinea

Location

University of Papua New Guinea

Port Moresby, Papua New Guinea

Location

MeSH Terms

Conditions

Yaws; Skin Ulcer

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor of healing outcomes through pictures will not know the arm of origen of the pictures .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Oriol Mitja

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 1, 2020
• Study Start: November 1, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 25, 2019
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of data for 1 year

Locations

PA (2)