None listed
Conditions
Brief summary
This trial aims to investigate the safety and efficacy of a proprietary tea tree gel (TTO) formulation (5% v/w) in comparison with an active comparator (i.e. 0.05% w/v potassium permanganate solution) for the treatment of tungiasis in children, over a 10-day period. TTO-gel is a water-based, transparent, skin formulation with excellent spreading properties and pleasing aesthetic characteristics. Unlike other tungiasis treatments, the TTO proprietary treatment offers a unique combination of parasiticidal, antibacterial, wound-healing, anti-inflammatory and anti-itch properties. We hypothesize that the TTO-gel is likely to be more effective than the control medication in treating tungiasis.
Interventions
Test group- treatment of tungiasis with a 5% (v/w), proprietary tea tree oil (TTO) gel
The feet of the participants will be washed with water and non-medicated soap, dried with a clean towel, and the participants’ toenails will be clipped to enable easier application of the test medication. Then, the test medication will be applied twice daily on days 1, 4 and 7 by trained study personnel (concerned case officers from participating schools). The mode of administration of the test medication is
Test group- treatment of tungiasis with a 5% (v/w), proprietary tea tree oil (TTO) gel The feet of the participants will be washed with water and non-medicated soap, dried with a clean towel, and the participants’ toenails will be clipped to enable easier application of the test medication. Then, the test medication will be applied twice daily on days 1, 4 and 7 by trained study personnel (concerned case officers from participating schools). The mode of administration of the test medication is by taking the required amount of the gel on the palms (up to 8g/day) and spreading it over the infested skin areas until it provides a full coverage of the affected area (skin surface of the feet up to the ankle) and the feet will then be left for 15 minutes to allow the medication to dry.
Sponsors
University of Canberra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Healthy volunteers
No
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).
Outcome results
None listed