To determine whether a targeted application of dimeticone has a higher efficacy to cure tungiasis (sand flea disease) than wetting the whole feet
| ISRCTN | ISRCTN74306878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74306878 |
| Secondary identifying numbers | Dimeticone II |
- Submission date
- 29/01/2014
- Registration date
- 18/02/2014
- Last edited
- 16/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
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?
March 2014 to April 2014
Who is funding the study?
German Doctors e.V., a non-governmental organization, as well as by private donations
Who is the main contact?
Prof. Hermann Feldmeier
hermann.feldmeier@charite.de
Contact information
Scientific
Hindenburgdamm 27
Berlin
12203
Germany
Study information
| Study design | Randomized trial using the left and the right foot of the participants as units of randomization |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Treatment of TUNGiasis (jiggers) with a targeted Application of a two-component DIMETicone |
| Study acronym | TUNGADIMET |
| Study hypothesis | 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 approval(s) | Ethics Committee, the Ministry of Health, Kampala, Uganda, 29/01/2013 |
| Condition | Tungiasis (sand flea disease) |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dimeticone |
| Primary outcome measure | 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 study start date | 01/03/2014 |
| Overall study end date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 55 |
| 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 |
| 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 | 01/03/2014 |
| Recruitment end date | 30/04/2014 |
Locations
Countries of recruitment
- Germany
- Uganda
Study participating centre
12203
Germany
Sponsor information
Not defined
Löbestraße 1a
Bonn
53173
Germany
"ROR" |
https://ror.org/001m0em47 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/03/2017 | Yes | No |
Editorial Notes
16/03/2017: Publication reference added.
