Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003651095100 Date of Approval: 05/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Exploring a tea tree oil (TTO)-based skin treatment for tungiasis in children
Official scientific title Treatment of tungiasis using a proprietary tea tree oil (TTO)-gel formulation in children: Protocol for a randomized, controlled, proof-of-principle trial
Brief summary describing the background and objectives of the trial Tungiasis is a neglected parasitic skin disease caused by the female sand fleas (Tunga penetrans), which is highly prevalent in central and south America, the Caribbean, and Sub-Saharan Africa. The disease inflicts pain and suffering on millions of people, particularly children, and yet it is neglected by donors, governments, the scientific community, and health care providers. Left untreated, tungiasis can lead to substantial human consequences including impaired sleep, school absenteeism social isolation, difficulty in walking, auto-amputation, childhood disability, and immobility in severe cases. There is no approved drug treatment for tungiasis, and the available treatment options are very limited. There is a clear need for new, safe, effective, affordable and culturally acceptable tungiasis treatment options. Topical treatment is most ideally suited in endemic settings and the treatment should be simple, enabling self-administration, and should be started as soon as symptoms appear so that it can kill the embedded parasite at an early stage, prevent secondary bacterial complications, and substantially reduce the occurrence of acute and chronic morbidities. This trial aims to investigate the safety and efficacy of a proprietary tea tree oil gel (TTO) formulation (5% v/w) in comparison with an active comparator (i.e. 0.05% w/v potassium permanganate solution) for the treatment of tungiasis in children, over a 10-day period. TTO-gel is a water-based, transparent, skin formulation with excellent spreading properties and pleasing aesthetic characteristics. Unlike other tungiasis treatments, the TTO proprietary treatment offers a unique combination of parasiticidal, antibacterial, wound-healing, anti-inflammatory and anti-itch properties.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2020
Actual trial start date
Anticipated date of last follow up 04/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ACTRN12619001610123 Australian New Zealand Clinical Trial Registry, ANZCTR
U111112432294 World Health Organization, Universal Trial Number
HREC20192114 University of Canberra Human Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tea tree oil gel Up to 8g/day Twice daily for three days (Days 1, 4 and 7) TTO-gel is a water-based, transparent, skin formulation with excellent spreading properties and pleasing aesthetic characteristics. It contains 5% (v/w) tea tree oil as an active ingredient. It will be applied by taking the required amount of the gel on the palms (up to 8g/day) and spreading it over the infested skin areas until it provides a full coverage of the affected area (skin surface of the feet up to the ankle) and the feet will then be left for 15 minutes to allow the medication to dry. 44
Control Group Potassium permanganate solution Up to 2.5 liters of 0.05% potassium permanganate solution solution Twice daily for three days (Day 1, 4 and 7) Potassium permanganate solution contains 0.05g of potassium permanganate in a liter of water. It will be applied by immersing and bathing the feet of the participants in a bucket containing a required volume of 0.05% potassium permanganate solution for 15 minutes. After air-drying the feet (for about 15 mins), petroleum jelly will be applied to soften the skin, which may get rough and irritated after bathing with potassium permanganate solution. 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 6–15 years with at least 1 viable stage II and Stage III embedded sand flea lesions according to the Fortaleza classification. A maximum of 2 viable sand flea lesions will be targeted and the lesions must be the sum of the feet and lesions located at the tip of toes, soles, and rim of heels will be selected properly. Children whose legal guardians are willing to give informed written consents after having been oral and written informed about benefits and potential risks of the trial Children with cluster lesions and manipulated lesions. Children with complicated lesions requiring antibiotic treatment. They will be referred to the nearby health facilities for appropriate clinical management. Children whose guardian/parents intend to change their place of residence during the study period Children with known histories of allergy to any of the study medications (Tea Tree Oil or other essential oils and potassium permanganate) Children have/had systemic or topical drugs or medications, including systemic antibiotics, which may interfere with the study results (based on the clinical team's assessment). Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/08/2019 University of Canberra Human Ethics Research Committee
Ethics Committee Address
Street address City Postal code Country
Kirinari Street Canberra 2617 Australia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of non-viable embedded sand fleas Day 10 or 9 days after the first treatment
Secondary Outcome Acute morbidity evaluation Days 0 or baseline, 5 and 10 or post treatment
Secondary Outcome The proportion of participants with adverse events Days 1 at PM, 4, 5, 7 and 10
Secondary Outcome Participant acceptability of the trial intervention/s Day 10 or 9 days after the first treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Riamajeshi Bright Start Academy Sotik Ikonge Road Nyamira 0800 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Canberra Kirinari St Canberra 2617 Australia University
COLLABORATORS
Name Street address City Postal code Country
Global School Partners Kenya Chapter Sotik Ikonge Road Nyamira 0800 Kenya
Global School Partners Australia Chapter Deakin Canberra 2603 Australia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Solomon Abrha Bezabh Solomon.Bezabh@canberra.edu.au +61262068928 Kirinari Street
City Postal code Country Position/Affiliation
Canberra 2601 Australia PhD student
Role Name Email Phone Street address
Public Enquiries Jackson Thomas Jackson.Thomas@canberra.edu.au +61262068928 Kirinari Street
City Postal code Country Position/Affiliation
Canberra 2601 Australia Academic staff and researcher
Role Name Email Phone Street address
Scientific Enquiries Jackson Thomas Jackson.Thomas@canberra.edu.au +61262068928 Kirinari Street
City Postal code Country Position/Affiliation
Canberra 2601 Australia Academic staff and researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The ethical approval for this study requires the individual participant data to be kept confidential. However, the deidentified pooled data per intervention will be made available through open access research publications. Informed Consent Form,Statistical Analysis Plan,Study Protocol The findings of the trial will be available through peer-reviewed journals as well as national and international scientific conference meetings once the primary outcome paper is published. The additional document types will also be shared during the publication. Through open access research publications, with no restriction.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information