Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr John Buckendahl


Contact details

Charite- Campus Benjamin Franklin
Department of Urology
Hindenburgdamm 30

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Intermittent application of a natural repellent against Tunga penetrans to reduce intensity of infestation and associated morbidity in an endemic area: a randomised controlled trial


Study hypothesis

1. Compare the efficacy of different schemes of prophylactic application of a natural repellent based on coconut oil to reduce infestation intensity and associated morbidity in a high transmission area
2. Reduce the pathology of tungiasis
3. Identify the frequency of application to effectively reduce tungiasis
4. Open new pathways for cost-effective control of tungiasis

Ethics approval

Ethical Committee of the Federal University of Ceará, Brazil, approved in January 2005

Study design

Randomised (permuted block design) controlled single centre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




After the admission examination the participants were randomised into three cohorts (A, B and C). In the first phase of the study individuals received a twice-daily application of Zanzarin® for a period of four weeks. It was anticipated that this reduced the number of embedded sand fleas to almost zero. Thereafter participants were examined again and the degree of the tungiasis-associated morbidity was assessed. These data provided the baseline for the subsequent study phase.

During a period of five months members of Cohort A applied the repellent every second week twice daily for one week and members of Cohort B every fourth week for one week. Cohort C served as control group and did not receive any protection.

During the intervention periods Zanzarin® was applied onto the feet by trained community health workers as described previously. The average volume applied was 3 ml per person and day. Prophylaxis was performed in the morning between 6 and 8 a.m. and in the evening between 6 and 8 p.m. The exact time of application was recorded for each study participant. The application of the repellent was regularly checked by random visits to the households of the study participants by one of the investigators.

In addition, at each examination the participants were asked whether the repellent had been applied regularly. This ensured that the repellent was applied exactly as defined in the study protocol, not spilled, given away for money or stolen. The participants were asked not to wash their feet for at least two hours after application of the repellent. However, they were allowed to take a shower whenever they wanted.

Intervention type



Not Applicable

Drug names


Primary outcome measures

The whole body surface was examined for the presence of immature, egg-producing or dead fleas and manipulated lesions. Tungiasis lesions were classified according to the Fortaleza Classification. The following findings were considered diagnostic for tungiasis:
1. Flea in statu penetrandi (stage I)
2. A dark and itching spot in the epidermis with a diameter of 1 to 2 mm, with or without local pain and itching (early lesion, stage II)
3. Lesions presenting as a white halo with a diameter of 3 to 10 mm with a central black dot (mature egg producing flea, stage III)
4. A brownish-black circular crust with or without surrounding necrosis of the epidermis (dead parasite, stage IV)

During monitoring the number of viable (stage I to III) and dead (stage IV) sand fleas and the total number of sand flea lesions were determined. Clinical pathology was documented every four weeks. Lesions manipulated by the patient (such as partially or totally eliminated fleas leaving a characteristic crater-like sore in the skin) and suppurative lesions caused by the use of non-sterile perforating instruments such as needles and thorns, were documented as well. The exact topographic localisation of each lesion, its stage, and appearance were documented on a visual record sheet.

Secondary outcome measures

Clinical pathology was assessed in a semi-quantitative manner using a previously elaborated severity score for acute tungiasis (SSAT) and a severity score for chronic tungiasis (SSCT). The SSAT score comprises the following signs and symptoms: erythema, oedema, pain upon pressure or spontaneously, itching, sleep disturbance due to itching, difficulty walking as indicated by an altered gait; abscess and suppuration as indicators of superinfection; fissures and ulcers as characteristic chronic skin defects. The score can take a value from 0 to 24 points. The SSCT ranges from 0 to 33 points and comprises the presence of nail deformation, nail loss, brilliant skin (an indicator of chronic oedema), deformation of toes; hypertrophic nail rim and perilesional desquamation; the latter two characteristics are indicators of repeated tungiasis experienced in the past.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Individuals with tungiasis identified with the assistance of community health workers
2. Aged 1 - 66 years, either sex
3. At least 5 embedded sand fleas in stage 1 to 4 of the Fortaleza Classification or a similar number of sand flea lesions manipulated with a perforating instrument

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Intended to change their place of residence during the next six months
2. Ulcerated lesions necessitating antibiotic treatment
3. Children aged less than one year

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Charite- Campus Benjamin Franklin

Sponsor information


Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Campus Benjamin Franklin
Institute of Microbiology and Hygiene
Hindenburgdamm 30

Sponsor type




Funder type


Funder name

DAAD-CAPES PROBRAL program (Germany) (ref: 152/02)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Engelhard Arzneimittel, Niederdorfelden (Germany) - provided the repellent (Zanzarin®) free of charge

Alternative name(s)

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

Publication summary

2007 results in

Publication citations

  1. Results

    Ariza L, Seidenschwang M, Buckendahl J, Gomide M, Feldmeier H, Heukelbach J, [Tungiasis: a neglected disease causing severe morbidity in a shantytown in Fortaleza, State of Ceará]., Rev. Soc. Bras. Med. Trop., 40, 1, 63-67.

Additional files

Editorial Notes