Introduction Tungiasis (sand flea disease or jigger infestation) is a neglected tropical disease caused by penetration of female sand fleas, Tunga penetrans, in the skin. The disease inflicts immense pain and suffering on millions of people, particularly children, in Latin America, the Caribbean and sub-Saharan Africa. Currently, there is no standard treatment for tungiasis, and a simple, safe and effective tungiasis treatment option is required. Tea tree oil (TTO) has long been used as a parasiticidal agent against ectoparasites such as headlice, mites and fleas with proven safety and efficacy data. However, current data are insufficient to warrant a recommendation for its use in tungiasis. This trial aims to generate these data by comparing the safety and efficacy of a 5% (v/w) TTO proprietary gel formulation with 0.05% (w/v) potassium permanganate (KMnO4) solution for tungiasis treatment.Methods and analysis This trial is a randomised controlled trial (RCT) in primary schools (n=8) in South-Western Kenya. The study will include school children (n=88) aged 6–15 years with a confirmed diagnosis of tungiasis. The participants will be randomised in a 1:1 ratio to receive a 3-day two times a day treatment of either 5% TTO gel or 0.05% KMnO4 solution. Two viable embedded sandflea lesions per participant will be targeted and the viability of these lesions will be followed throughout the study using a digital handheld microscope. The primary outcome is the proportion of observed viable embedded sand fleas that have lost viability (non-viable lesions) by day 10 (9 days after first treatment). Secondary outcomes include improvement in acute tungiasis morbidities assessed using a validated severity score for tungiasis, safety assessed through adverse events and product acceptability assessed by interviewing the participants to rate the treatment in terms of effectiveness, side effects, convenience, suitability and overall satisfaction.Ethics and dissemination The trial protocol has been reviewed and approved by the University of Canberra Human Research Ethics Committee (HREC-2019-2114). The findings of the study will be presented at scientific conferences and published in a peer-reviewed journal.Trial registration numbers Australian New Zealand Clinical Trials Registry (ACTRN12619001610123); PACTR202003651095100 and U1111-1243-2294.
Publications
Treatment of tungiasis using a tea tree oil-based gel formulation: protocol for a randomised controlled proof-of-principle trial. BMJ Open [Internet]. 2021;11(7):e047380. WebsiteAbstract
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Access and Use of Information by Rural Communities in Arid and Semi-Arid Lands (ASALs) of Kenya: The Case of Maarifa Centres. Journal of Information and Knowledge Management. 2020;10(5).
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A Case Report of Pregnancy Outcome Following Four Consecutive Complete Molar Pregnancies: Review of Genetic Basis of Recurrent Molar Pregnancies and Pillars of Management. J Gynecol Women’s Health. 2020; 19 (J Gynecol Women’s HealthVolume 19 Issue 2 - June 2020):DOI: 10.19080/JGWH.2020.18.556008 .
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Causality between Foreign Trade and Economic Growth: Evidence from Kenya (1970-2017). Target Journal of Economics. 2020;2(1):225-235.
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Challenges and innovations in achieving zero hunger and environmental sustainability through the lens of sub-Saharan Africa. Outlook on Agriculture. 2020:0030727020975778.
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Combustion synthesis of battery-type positive electrodes for robust aqueous Hybrid supercapacitor. Journal of Energy storage. 2020.
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Comparative Analysis of Spectral Theory of Second Order Difference and Differential Operators with Unbounded Odd Coefficient. Kyungpook Mathematical Journal. 2020;60:297–305.
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Contributions of partnerships to conservation and development: Insights from Amboseli. Tourism Review International. 2020.
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Corporate Governance Practices and Tax Disclosure among Firms Listed at the Nairobi Securities Exchange, Kenya. Journal of Finance and Accounting. 2020;4:61–72.
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Detection of types of HPV among HIV‐infected and HIV‐uninfected Kenyan women undergoing cryotherapy or loop electrosurgical excision procedure. International Journal of Gynecology & Obstetrics. 2020.
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Diversity of Cultural Tourism Attractions in Nairobi Urban Destination. Journal of Tourism Management Research. 2020;7:247–257.
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Does Portfolio Quality Influence Financial Sustainability? A Case of Microfinance Institutions in Kenya. Journal of Economics and Financial Analysis. 2020;3:23–39.
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Does Quality of Corporate Governance affect Financial Performance of listed firms in NSE, Kenya?. African Journal of Education, Science and Technology. 2020;5(4):50-63.
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Dynamic Modelling of Low-Temperature Batch In-Bin Drying of Cobed Seed Maize: an Industrial Case Study. Journal of Biosystems Engineering. 2020:1–12.
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