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

Phase 2

• Conditions: Paediatrics; Skin and Connective Tissue Diseases

• Registration Number: PACTR202003651095100
• Lead Sponsor: niversity of Canberra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Children aged 6–15 years with at least 1 viable stage II and Stage III embedded sand flea lesions according to the Fortaleza classification. A maximum of 2 viable sand flea lesions will be targeted and the lesions must be the sum of the feet and lesions located at the tip of toes, soles, and rim of heels will be selected properly.
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of non-viable embedded sand fleas

Secondary Outcome Measures

Name	Time	Method
Acute morbidity evaluation;The proportion of participants with adverse events;Participant acceptability of the trial intervention/s