Rationale: Tungiasis, a parasitic skin disease (sand flea disease) inflicts pain and suffering on millions of people in Sub-Saharan Africa and South America, and yet it gets little attention from donors, scientists, governments and even health workers. There is no highly effective, widely available, safe and simple treatment. Instead communities in their desperation remove the embedded fleas using unsterilized pins and plant thorns which carry huge risk of secondary infection with bacteria and possibly even HIV and Hepatitis B. The government of Kenya currently recommends the use of potassium permanganate and Vaseline, but this has been demonstrated in a recent trial to have only 39% efficacy. Some communities use their own herbal remedies for sand flea control. In Kilifi County, a mix of natural products based mostly on neem oil (Azadirachta indica),) and coconut oil (Cocos nucifera) known as JIGFIX, is used by local community self-help groups. Coconut oil is widely used in the food and cosmetics industry and neem oil as an antiseptic, and used for medical and agricultural insect control. Their safety and beneficial properties have been shown in various contexts. Their combined effect on pathology, bacteria, fungi or insects has never been tested scientifically.

Primary Objective: To determine whether a mix of neem and coconut oils kills a higher proportion of embedded jiggers than the current standard of potassium permanganate and Vaseline, in 7 days.

Secondary Objectives:

·         To determine whether neem and coconut oil reduces inflammation, pain and itching better than the standard treatment, in 7 days.

·          To determine the safety of the neem and coconut oil mix for topical use.

Methods: The study will follow a randomized controlled trial design. One hundred school children aged 6-14 years with at least one clear live, embedded flea at stage II and III in one foot will be enrolled. Half the children will be treated with the neem and coconut oil mix and the other half with potassium permanganate. The study will take place in Malindi Sub-County of Kilifi County. The embedded fleas of each participant will be monitored every other day for 7 days after treatment using a digital handheld microscope for signs of viability, abnormal development and inflammation. The children will also be asked to assess their level of pain and itching, the major symptoms caused by embedded fleas.

Application of Results: If the neem and coconut oil mix proves to be more effective at killing embedded fleas than the current standard of potassium permanganate, this study will have huge implications, not only for Kenya, but also for all countries where jiggers are endemic. The neem and coconut oil mix will be the only effective, safe and simple treatment available.