Exploring a tea tree oil (TTO)-based skin treatment for tungiasis in childre

Phase 2

• Conditions: Tungiasis (sand flea disease); Skin - Dermatological conditions; Infection - Other infectious diseases; Public Health - Other public health

• Registration Number: ACTRN12619001610123
• Lead Sponsor: niversity of Canberra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Children aged 6-15 years with at least 1 viable (stage II and Stage III) lesions according to the Fortaleza classification and a maximum of 2 viable sand flea lesions will be targeted.
2. Children whose legal guardians are willing to give informed written consents after having been oral and written informed about benefits and potential risks of the trial

Exclusion Criteria

1. Children with cluster lesions and manipulated lesions.
2. Children with complicated lesions requiring antibiotic treatment. They will be referred to the nearby health facilities for appropriate clinical management.
3. Children whose guardian/parents intend to change their place of residence during the study period
4. Children with known history of allergy to any of the study medications (Tea Tree Oil or other essential oils and potassium permanganate)
5. Individuals have/had systemic or topical drugs or medications, including systemic antibiotics, which may interfere with the study results (based on clinical team's assessment).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of non-viable fleas <br><br>Determination of viability of the sand flea lesions will be performed using a handheld digital video microscope, assisted with pictorial flipcharts. Expulsion of eggs, excretion of faecal threads, excretion of faecal liquid, and pulsations/contractions in the abdomen of the embedded flea will be considered as four viability signs and lesions with 2 out of 4 viability signs will be recorded viable. Lesions will be considered dead (non-viable) if their viability signs are not detected during the 10 min follow-up examinations. Differences in the proportion of non-viable lesions between test and control groups will be compared and presented with their respective confidence intervals at 95% and p-values. [Day 10 (9 days after the first treatment).]