Prevention of tungiasis - associated morbitity in a resource-poor community in Madagascar

Morbidity prevention of tunga penetrans in a resource-poor community in Madagascar: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11415557

Enrollment

225

Registered

2011-09-28

Start date

2011-08-01

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Tungiasis Infections and Infestations Tungiasis

Interventions

Three cohort groups: 1. Zanzarin® ( active ingredients: capric acid, cocos nucifera, citronellol) : topical application 5 ml twice daily on the feet and ankles for 3 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. More than or equal to 10 tungiasis lesions 2. Aged more than or equal to 5 years 3. 4-5 days of permanence in the village per week 4. Permanence in the village during next 4 months 5. The participants or their legal guardian have signed the informed written consent

Exclusion criteria

Exclusion criteria: 1. Less than or equal to 10 tungiasis lesions 2. Aged less than 5 years 3. Less than 4-5 days of permanence in the village per week 4. Less than 4 months permanence in the village 5. The participants or their legal guardian have not signed the informed written consent

Design outcomes

Primary

Measure	Time frame
To assess the impact of the different interventions the following outcome measures will be compared every two weeks during three month. Lesion stage will be assessed according the Fortaleza Classification. 1. Total number of lesions located at the feet 2. Number of viable lesions (stage 1-3) 3. Number of non-viable lesions (stage 4) 4. Ratio of viable lesions (stage 1 to 3) divided by total number of lesions 5. Ratio of non-viable lesions (stage 4) divided by total number of lesions 6. Percentage of participants without viable lesions at the end of the study 7. Severity score for acute and chronic tungiasis-associated morbidity To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.	—

Measure

Time frame

To assess the impact of the different interventions the following outcome measures will be compared every two weeks during three month. Lesion stage will be assessed according the Fortaleza Classification. 1. Total number of lesions located at the feet 2. Number of viable lesions (stage 1-3) 3. Number of non-viable lesions (stage 4) 4. Ratio of viable lesions (stage 1 to 3) divided by total number of lesions 5. Ratio of non-viable lesions (stage 4) divided by total number of lesions 6. Percentage of participants without viable lesions at the end of the study 7. Severity score for acute and chronic tungiasis-associated morbidity To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.

—

Secondary

Measure	Time frame
To assess the impact of the different interventions the following outcome measures will be compared: 1. Percentage of participants without viable lesions at the end of the study 2. Modified severity score for acute and chronic tungiasis-associated morbidity To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.	—

Measure

Time frame

To assess the impact of the different interventions the following outcome measures will be compared: 1. Percentage of participants without viable lesions at the end of the study 2. Modified severity score for acute and chronic tungiasis-associated morbidity To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.

—

Countries

Madagascar

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026