Interventional study against Tunga penetrans

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16910507

Enrollment

140

Registered

2010-01-07

Start date

2005-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tungiasis Infections and Infestations Other infestations

Interventions

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 peri

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026