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

Jackson Thomas, Rachel Davey, Gregory M. Peterson, Christine Carson, Shelley F. Walton, Tim Spelman, Tom Calma, Pascale Dettwiller, Jacinta Tobin, Faye McMillan, Paul Collis, Mark Naunton, Sam Kosari, Julia K. Christenson, Andrew Bartholomaeus, John McEwen, Peter Fitzpatrick, Kavya E. Baby

Research output: Contribution to journalArticle

2 Citations (Scopus)
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Abstract

Introduction In 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 analysis A 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 dissemination The 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 registration ACTRN12617000902392; Pre-results.

Original languageEnglish
Article numbere018507
Pages (from-to)1-10
Number of pages10
JournalBMJ Open
Volume8
Issue number5
DOIs
Publication statusPublished - 31 May 2018

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Tea Tree Oil
Scabies
Randomized Controlled Trials
Gels
Permethrin
Bacterial Infections
Indigenous Health Services
Pragmatic Clinical Trials
Outcome Assessment (Health Care)
Northern Territory
Ivermectin
Research Ethics Committees
Therapeutics
Random Allocation
Anti-Infective Agents
Coinfection
Chronic Renal Insufficiency
Ethics
Publications
Heart Diseases

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Thomas, J., Davey, R., Peterson, G. M., Carson, C., Walton, S. F., Spelman, T., ... Baby, K. E. (2018). Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children: Protocol for a randomised controlled trial. BMJ Open, 8(5), 1-10. [e018507]. https://doi.org/10.1136/bmjopen-2017-018507
Thomas, Jackson ; Davey, Rachel ; Peterson, Gregory M. ; Carson, Christine ; Walton, Shelley F. ; Spelman, Tim ; Calma, Tom ; Dettwiller, Pascale ; Tobin, Jacinta ; McMillan, Faye ; Collis, Paul ; Naunton, Mark ; Kosari, Sam ; Christenson, Julia K. ; Bartholomaeus, Andrew ; McEwen, John ; Fitzpatrick, Peter ; Baby, Kavya E. / Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children : Protocol for a randomised controlled trial. In: BMJ Open. 2018 ; Vol. 8, No. 5. pp. 1-10.
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abstract = "Introduction In 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 analysis A 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 dissemination The 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 registration ACTRN12617000902392; Pre-results.",
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Thomas, J, Davey, R, Peterson, GM, Carson, C, Walton, SF, Spelman, T, Calma, T, Dettwiller, P, Tobin, J, McMillan, F, Collis, P, Naunton, M, Kosari, S, Christenson, JK, Bartholomaeus, A, McEwen, J, Fitzpatrick, P & Baby, KE 2018, 'Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children: Protocol for a randomised controlled trial', BMJ Open, vol. 8, no. 5, e018507, pp. 1-10. https://doi.org/10.1136/bmjopen-2017-018507

Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children : Protocol for a randomised controlled trial. / Thomas, Jackson; Davey, Rachel; Peterson, Gregory M.; Carson, Christine; Walton, Shelley F.; Spelman, Tim; Calma, Tom; Dettwiller, Pascale; Tobin, Jacinta; McMillan, Faye; Collis, Paul; Naunton, Mark; Kosari, Sam; Christenson, Julia K.; Bartholomaeus, Andrew; McEwen, John; Fitzpatrick, Peter; Baby, Kavya E.

In: BMJ Open, Vol. 8, No. 5, e018507, 31.05.2018, p. 1-10.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children

T2 - Protocol for a randomised controlled trial

AU - Thomas, Jackson

AU - Davey, Rachel

AU - Peterson, Gregory M.

AU - Carson, Christine

AU - Walton, Shelley F.

AU - Spelman, Tim

AU - Calma, Tom

AU - Dettwiller, Pascale

AU - Tobin, Jacinta

AU - McMillan, Faye

AU - Collis, Paul

AU - Naunton, Mark

AU - Kosari, Sam

AU - Christenson, Julia K.

AU - Bartholomaeus, Andrew

AU - McEwen, John

AU - Fitzpatrick, Peter

AU - Baby, Kavya E.

PY - 2018/5/31

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N2 - Introduction In 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 analysis A 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 dissemination The 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 registration ACTRN12617000902392; Pre-results.

AB - Introduction In 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 analysis A 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 dissemination The 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 registration ACTRN12617000902392; Pre-results.

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KW - infection control

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