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

Introduction Tungiasis (sand flea disease or jigger infestation) is a neglected tropical caused by penetration of female sand fleas, Tunga penetrans , in the skin. The inflicts immense pain and suffering on millions people, particularly children, Latin America, Caribbean sub-Saharan Africa. Currently, there no standard treatment for tungiasis, simple, safe effective tungiasis option required. Tea tree oil (TTO) has long been used as parasiticidal agent against ectoparasites such headlice, mites fleas with proven safety efficacy data. However, current data are insufficient to warrant recommendation its use tungiasis. This trial aims generate these comparing 5% (v/w) TTO proprietary gel formulation 0.05% (w/v) potassium permanganate (KMnO 4 ) solution treatment. Methods analysis randomised controlled (RCT) primary schools (n=8) South-Western Kenya. study will include school children (n=88) aged 6–15 years confirmed diagnosis participants be 1:1 ratio receive 3-day two times day either KMnO solution. Two viable embedded sandflea lesions per participant targeted viability followed throughout using digital handheld microscope. outcome proportion observed that have lost (non-viable lesions) 10 (9 days after first treatment). Secondary outcomes improvement acute morbidities assessed validated severity score through adverse events product acceptability interviewing rate terms effectiveness, side effects, convenience, suitability overall satisfaction. Ethics dissemination protocol reviewed approved University Canberra Human Research Committee (HREC-2019-2114). findings presented at scientific conferences published peer-reviewed journal. Trial registration numbers Australian New Zealand Clinical Trials Registry (ACTRN12619001610123); PACTR202003651095100 U1111-1243-2294.