Protocol for a Randomized Control Trial for Tungiasis Treatment in Homa Bay County, Kenya: Dimeticone versus Sodium Carbonate.

Tungiasis, a World Health Organization neglected tropical disease, is caused by the female sand flea. Most clinical trials for tungiasis use expensive or impractical drugs, which are difficult for residents to use. However, in western Kenya, communities successfully treat tungiasis with sodium carbonate. We hypothesise that the topical risk-difference of 5% sodium carbonate is no more than 10% non-inferior to dimeticone (NYDA®) for tungiasis treatment. This is a protocol for a non-inferiority study, which will be randomised and with an observer-blinded control. The study will have two arms: 5% sodium carbonate and NYDA®, one on each foot, and will take place at state primary schools in Homa Bay County, Kenya. Fleas identified among school children aged 8-14 years with sand-flea lesions will be enrolled in the study. For each participant, the viability of the embedded fleas, clinical signs including inflammation, and symptoms will be monitored for seven days after treatment. The proportion of dead fleas will be compared in the primary analysis. All adverse events will be monitored throughout the study period. We expect to identify the most effective treatment between sodium carbonate and NYDA® for tungiasis, which can be adopted in the community.