Plain English Summary
Background and summary
Tungiasis (sand flea disease) is a neglected tropical parasitic disease. It occurs in many countries in South America and sub-Saharan Africa and effects the poorest of the poor. 99% of the parasites penetrate into the skin of the feet. Parts of the body which are particularly affected are the toes, the sole, the lateral rim and the heel. In the endemic areas, prevalences are up to 70% in children and 30% in the general population.
Sand fleas burrowed in the skin elicit an intense inflammatory response. Acute and chronic inflammation results in fissures, ulcers, pain and difficulty walking. Repeated infections are debilitating and eventually lead to mutilation of the toes.
In a previous study it was shown that wetting the skin of the feet three times within 10 minutes with a combination of two dimeticones with a very low viscosity killed 78% of the parasite.
It is assumed that a repeated targeted application of dimeticone to the site where parasites are burrowed in the skin will increase the efficacy of the treatment to ≥ 95%. Since the application of dimeticone can be performed with minimal input from the health sector, this treatment will become the core measure in national control programs against tungiasis currently being developed by the Ministries of Health in several East African countries. The study will be performed in Busoga Region, Uganda, north of Lake Victoria, an area which is notoriously affected by tungiasis.
Who can participate?
55 school children between 6 and 15 years with tungiasis will be admitted to the study.
Who does the study involve?
Every day, 3 - 4 school children are admitted to the study and are followed up daily during 7 days. (on the basis of having at least two viable parasites on each foot). The left and the right foot of each participant are randomly allocated to one of two treatments: either the standard treatment (wetting the foot with dimeticone 3 times during 10 minutes) or the targeted treatment (application of the dimeticone directly on the abdominal cone of the parasite which protrudes through the skin with the help of a syringe). At the end of the study, the following are compared between left and right feet:
- % of viable parasites that died after the application of dimeticone
- % of parasites that did not develop in a normal manner
- regression of the intensity of local inflammation
What are the possible benefits and risks of participating?
A direct benefit for the participants is that they are relieved from a parasitic skin disease for which there is currently no effective treatment. As dimeticones are wholly non-toxic, the treatment does not pose any health risk.
Where is the study run from?
The study has been set up by the Institute of Microbiology and Hygiene of the Charité University Medicine, Berlin, Germany, together with the Ministry of Health, Kampala, Uganda. It will take place in Bugiri, Busoga region, Uganda.
When is study starting and how long is it expected to run for?
It is anticipated that recruitment will start at the beginning of March 2014 and is expected to end on April 30, 2014.
Who is funding the study?
The study is funded by German Doctors e.V., a non-governmental organization as well as by private donations.
Who is the main contact?
Prof. Hermann Feldmeier
Treatment of TUNGiasis (jiggers) with a targeted Application of a two-component DIMETicone
It is assumed that a repeated targeted application of dimeticone to the site where parasites are burrowed in the skin has a higher efficacy in killing embedded sand fleas than simply wetting the skin of the feet with dimeticone (the standard procedure).
Ethics Committee, the Ministry of Health, Kampala, Uganda, January 29, 2013
Randomized trial using the left and the right foot of the participants as units of randomization.
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Tungiasis (sand flea disease), a neglected tropical disease
The left and the right foot of each participant are randomized to either receive the standard treatment (wetting the foot with dimeticone 3 times during 10 minutes) or the targeted treatment: application of the dimeticone directly on the abdominal cone of the parasite (which protrudes through the skin) with the help of a syringe.
Primary outcome measures
1. % of viable parasites that died after the application of dimeticone. Viability is determined with a portable digital video microscope.
2. % of parasites that did not develop in a normal manner
Followed up daily during 7 days
Secondary outcome measures
Regression of the intensity of local inflammation
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. School children between 6 and 15 years with at least two viable sand fleas in the skin of each foot.
2. Care-takers are requested to sign an informed written consent form for the participant before admission.
Target number of participants
Participant exclusion criteria
Children with severe bacterial superinfection of tungiasis lesions are not eligible and will be referred to the next primary health care center for antibiotic treatment.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
German Doctors e.V., a non-governmental organization (Germany)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting