Abstract:
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 (KMnO 4 ) 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% KMnO 4 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.
