Treatment of tungiasis using a proprietary tea tree oil (TTO)-gel formulation in children: Protocol for a randomized, controlled, proof-of-principle trial

niversity of Canberra0 个研究点目标入组 88 人开始时间: 2020年2月26日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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

•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).

发起方

niversity of Canberra