Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children: protocol for a randomised controlled trial

Abstract

IntroductionIn remote Aboriginal communities in Australia, scabies affects 7 out of 10 children before their first birthday. This is more than six times the rate seen in the rest of the developed world. Scabies infestation is frequently complicated by bacterial infection, leading to the development of skin sores and other more serious consequences, such as septicaemia and chronic heart and kidney diseases. Tea tree oil (TTO) has been used as an antimicrobial agent for several decades with proven clinical efficacy. Preclinical investigations have demonstrated superior scabicidal properties of TTO compared with widely used scabicidal agents, such as permethrin 5% cream and ivermectin. However, current data are insufficient to warrant a broad recommendation for its use for the management of scabies because previous studies were small or limited to in vitro observations.Methods and analysisA pragmatic first trial will examine the clinical efficacy of a simple and low-cost TTO treatment against paediatric scabies and the prevention of associated secondary bacterial infections, with 1:1 randomisation of 200 participants (Aboriginal children, aged 5–16 years and living in remote Australia) into active control (permethrin 5% cream) and treatment (5% TTO gel) groups. The primary outcome for the study is clinical cure (complete resolution). Secondary outcome measures will include relief of symptoms, recurrence rate, adverse effects, adherence to treatment regimen and patient acceptability.Ethics and disseminationThe project has received approvals from the University of Canberra Human Research Ethics Committee (HREC 16-133), Wurli-Wurlinjang Health Service Indigenous subcommittee and the Aboriginal Medical Services Alliance Northern Territory reference group. The results of this study will be published in core scientific publications, with extensive knowledge exchange activities with non-academic audiences throughout the duration of the project.Trial registrationACTRN12617000902392; Pre-results.

High burden of infectious disease and antibiotic use in early life in Australian Aboriginal communities

“…Ultimately, reductions in antibiotic use will only occur with reductions in the prevalence of infections, highlighting the importance of engaging with Aboriginal communities to better understand the social determinants underlying the infectious diseases burden. Exploration of traditional medicines such as tea tree oil for their laboratory and clinical efficacy against scabies may also serve as a connection point between Western and Aboriginal perspectives 38,39 …”

“…Exploration of traditional medicines such as tea tree oil for their laboratory and clinical efficacy against scabies may also serve as a connection point between Western and Aboriginal perspectives. 38,39 This analysis was strengthened by pooling data from three separate but related studies. Each of these datasets was collected with very similar methodology and from the same geographical region.…”

The public health control of scabies: priorities for research and action

“…21 The effectiveness and safety profile of novel topical agents, including tea tree oil, for individual case management should be further explored. [101][102][103][104][105][106][107][108] Oral medicines have clear advantages for treatment of asymptomatic individuals, and particularly for treatment of whole populations through mass drug administration (MDA), where oral medications are more likely to be accepted and ingestion can be directly observed.…”

Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties

“…The chemical composition of TTO is well recognized and includes terpene hydrocarbons, monoterpenes, sesquiterpenes, and their associated alcohols. The volatile oil feature of TTO is due to the terpenes, and 90% of TTO evaporates fast from the epidermis, interfering with its absorption [ 8 ]. Terpinen-4-ol is the primary active component with concentration ranging between 30 and 48% [ 2 ].…”