Yaws; CutaneousPhase 2NCT04453124
An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
A Phase 2 study testing Topical antiseptic treatment in people with Yaws; Cutaneous and Cutaneous Ulcer, run by Oriol Mitja at 2 sites in Papua New Guinea.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Yaws; Cutaneous, Cutaneous Ulcer, Yaws
- What is being tested?
- Topical antiseptic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesPapua New Guinea
- Study dates
- 1 Nov 2019to 25 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Papua New Guinea2 sites
Lihir Medical Centre
Londolovit, New Ireland Province, 034
University of Papua New Guinea
Port Moresby
About this study
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.
Read the 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
- Being tested
- Topical antiseptic treatment
- Medical subject headings
- Yaws, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical antiseptic treatmentBiological
Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Topical antiseptic treatment |
| Chlorhexidine (Topical) | Active comparator | Chlorhexidine, topical solution, 50ul, daily, for 2 days Receives: Biological: Topical antiseptic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Clinical Healing in each arm
surface reduction by more than 50%
Measured: 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.
Measured: 21 days
Secondary outcomes (1)
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
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Nov 2019
- Primary completion22 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yaws; CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oriol Mitja
- Sponsor type
- University, hospital or other
- Collaborators
- University of Papua New Guinea, The Royal Botanic Gardens, Kew
- Responsible party
- Sponsor-investigator, Oriol Mitja, Lihir Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453124
- Sponsor's protocol ID
- SAPKOKOPO
- Status last verified
- Sep 2020
- First submitted
- 21 Jun 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual variables will be available through direct contact with corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Accessible Low-cost Plant Treatment for Cutaneous Ulcers
- ClinicalTrials.gov ID
- NCT04453124
- Acronym / sponsor ID
- SAPKOKOPO
- Conditions
- Yaws; Cutaneous, Cutaneous Ulcer, Yaws
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Oriol MitjaUniversity, hospital or other
- Collaborators
- University of Papua New Guinea, The Royal Botanic Gardens, Kew
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soap and Water | No intervention | –Standard of care using soap and water |
| Ficus Septica Sap | Experimental | Biological: Topical antiseptic treatmentFicus Septica Sap, topical cream, 50ul, daily, for 2 days |
| Chlorhexidine (Topical) | Active comparator | Biological: Topical antiseptic treatmentChlorhexidine, topical solution, 50ul, daily, for 2 days |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical antiseptic treatmentPrevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds. | Biological | Chlorhexidine (Topical), Ficus Septica Sap |
Primary outcome
Number of participants with Clinical Healing in each arm
Time frame: 21 days
surface reduction by more than 50%
Number of participants with Clinical Healing in each arm
Time frame: 21 days
Ulcer healing determined by a professional dermatologist, described as as: appearance of granulation tissue, healed borders, dry ulcer, no exudation.
1 secondary outcome
Changes in wound microbiology
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: Yes. All individual variables will be available through direct contact with corresponding author
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Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical antiseptic treatment in people with Yaws; Cutaneous and Cutaneous Ulcer, run by Oriol Mitja at 2 sites in Papua New Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Clinical Healing in each arm (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.