An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
Primary Purpose
Yaws; Cutaneous, Cutaneous Ulcer, Yaws
Status
Completed
Phase
Phase 2
Locations
Papua New Guinea
Study Type
Interventional
Intervention
Topical antiseptic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Yaws; Cutaneous
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
Sites / Locations
- Lihir Medical Centre
- University of Papua New Guinea
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Soap and Water
Ficus Septica Sap
Chlorhexidine (Topical)
Arm Description
Standard of care using soap and water
Ficus Septica Sap, topical cream, 50ul, daily, for 2 days
Chlorhexidine, topical solution, 50ul, daily, for 2 days
Outcomes
Primary Outcome Measures
Number of participants with Clinical Healing in each arm
surface reduction by more than 50%
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04453124
First Posted
June 21, 2020
Last Updated
September 1, 2020
Sponsor
Oriol Mitja
Collaborators
The University of Papua New Guinea, The Royal Botanic Gardens, Kew
1. Study Identification
Unique Protocol Identification Number
NCT04453124
Brief Title
An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
Official Title
An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oriol Mitja
Collaborators
The University of Papua New Guinea, The Royal Botanic Gardens, Kew
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yaws; Cutaneous, Cutaneous Ulcer, Yaws
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessor of healing outcomes through pictures will not know the arm of origen of the pictures .
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soap and Water
Arm Type
No Intervention
Arm Description
Standard of care using soap and water
Arm Title
Ficus Septica Sap
Arm Type
Experimental
Arm Description
Ficus Septica Sap, topical cream, 50ul, daily, for 2 days
Arm Title
Chlorhexidine (Topical)
Arm Type
Active Comparator
Arm Description
Chlorhexidine, topical solution, 50ul, daily, for 2 days
Intervention Type
Biological
Intervention Name(s)
Topical antiseptic treatment
Intervention Description
Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.
Primary Outcome Measure Information:
Title
Number of participants with Clinical Healing in each arm
Description
surface reduction by more than 50%
Time Frame
21 days
Title
Number of participants with Clinical Healing in each arm
Description
Ulcer healing determined by a professional dermatologist, described as as: appearance of granulation tissue, healed borders, dry ulcer, no exudation.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Changes in wound microbiology
Description
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
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lihir Medical Centre
City
Londolovit
State/Province
New Ireland Province
ZIP/Postal Code
034
Country
Papua New Guinea
Facility Name
University of Papua New Guinea
City
Port Moresby
Country
Papua New Guinea
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
We'll reach out to this number within 24 hrs