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Treatment of tungiasis using a tea tree oil-based gel formulation: protocol for a randomised controlled proof-of-principle trial


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Abrha, S, Christenson, JK, McEwen, J, Tesfaye, W, Vaz Nery, S, Chang, AY, Spelman, T, Kosari, S, Kigen, G, Carroll, S, Heukelbach, J, Feldmeier, H, Bartholomaeus, A, Daniel, M, Peterson, GM ORCID: 0000-0002-6764-3882 and Thomas, J 2021 , 'Treatment of tungiasis using a tea tree oil-based gel formulation: protocol for a randomised controlled proof-of-principle trial' , BMJ Open, vol. 11 , pp. 1-9 , doi: 10.1136/bmjopen-2020-047380.

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Introduction: Tungiasis (sand flea disease or jiggerinfestation) is a neglected tropical disease caused bypenetration of female sand fleas, Tunga penetrans, in theskin. The disease inflicts immense pain and suffering onmillions of people, particularly children, in Latin America,the Caribbean and sub-Saharan Africa. Currently, there isno standard treatment for tungiasis, and a simple, safeand effective tungiasis treatment option is required. Teatree oil (TTO) has long been used as a parasiticidal agentagainst ectoparasites such as headlice, mites and fleaswith proven safety and efficacy data. However, currentdata are insufficient to warrant a recommendation for itsuse in tungiasis. This trial aims to generate these databy comparing the safety and efficacy of a 5% (v/w) TTOproprietary gel formulation with 0.05% (w/v) potassiumpermanganate (KMnO4) solution for tungiasis treatment.Methods and analysis: This trial is a randomisedcontrolled trial (RCT) in primary schools (n=8) in SouthWestern Kenya. The study will include school children(n=88) aged 6–15 years with a confirmed diagnosis oftungiasis. The participants will be randomised in a 1:1 ratioto receive a 3-day two times a day treatment of either 5%TTO gel or 0.05% KMnO4 solution. Two viable embeddedsandflea lesions per participant will be targeted and theviability of these lesions will be followed throughout thestudy using a digital handheld microscope. The primaryoutcome is the proportion of observed viable embeddedsand fleas that have lost viability (non-viable lesions) byday 10 (9 days after first treatment). Secondary outcomesinclude improvement in acute tungiasis morbiditiesassessed using a validated severity score for tungiasis,safety assessed through adverse events and productacceptability assessed by interviewing the participants torate the treatment in terms of effectiveness, side effects,convenience, suitability and overall satisfaction.

Item Type: Article
Authors/Creators:Abrha, S and Christenson, JK and McEwen, J and Tesfaye, W and Vaz Nery, S and Chang, AY and Spelman, T and Kosari, S and Kigen, G and Carroll, S and Heukelbach, J and Feldmeier, H and Bartholomaeus, A and Daniel, M and Peterson, GM and Thomas, J
Keywords: tungiasis, randomised clinical trial, tea tree oil, efficacy, safety
Journal or Publication Title: BMJ Open
Publisher: B M J Group
ISSN: 2044-6055
DOI / ID Number: 10.1136/bmjopen-2020-047380
Copyright Information:

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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