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

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

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

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

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Publisher:: BMJ PUBLISHING GROUP
Publication Type:: Journal Article
Citation:: BMJ Open, 2018, 8, (5), pp. e018507
Issue Date:: 2018-05-31

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Field	Value	Language
dc.contributor.author	Thomas, J
dc.contributor.author	Davey, R
dc.contributor.author	Peterson, GM
dc.contributor.author	Carson, C
dc.contributor.author	Walton, SF
dc.contributor.author	Spelman, T
dc.contributor.author	Calma, T
dc.contributor.author	Dettwiller, P
dc.contributor.author	Tobin, J
dc.contributor.author	McMillan, F https://orcid.org/0000-0002-9441-7805
dc.contributor.author	Collis, P
dc.contributor.author	Naunton, M
dc.contributor.author	Kosari, S
dc.contributor.author	Christenson, JK
dc.contributor.author	Bartholomaeus, A
dc.contributor.author	McEwen, J
dc.contributor.author	Fitzpatrick, P
dc.contributor.author	Baby, KE
dc.date.accessioned	2024-03-05T23:28:21Z
dc.date.available	2024-03-05T23:28:21Z
dc.date.issued	2018-05-31
dc.identifier.citation	BMJ Open, 2018, 8, (5), pp. e018507
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/176153
dc.description.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.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ PUBLISHING GROUP
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2017-018507
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.classification	52 Psychology
dc.subject.mesh	Adolescent
dc.subject.mesh	Anti-Infective Agents, Local
dc.subject.mesh	Child
dc.subject.mesh	Child, Preschool
dc.subject.mesh	Female
dc.subject.mesh	Health Services, Indigenous
dc.subject.mesh	Humans
dc.subject.mesh	Kaplan-Meier Estimate
dc.subject.mesh	Male
dc.subject.mesh	Northern Territory
dc.subject.mesh	Proportional Hazards Models
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Scabies
dc.subject.mesh	Tea Tree Oil
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Humans
dc.subject.mesh	Scabies
dc.subject.mesh	Tea Tree Oil
dc.subject.mesh	Anti-Infective Agents, Local
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Proportional Hazards Models
dc.subject.mesh	Adolescent
dc.subject.mesh	Child
dc.subject.mesh	Child, Preschool
dc.subject.mesh	Health Services, Indigenous
dc.subject.mesh	Northern Territory
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Kaplan-Meier Estimate
dc.subject.mesh	Adolescent
dc.subject.mesh	Anti-Infective Agents, Local
dc.subject.mesh	Child
dc.subject.mesh	Child, Preschool
dc.subject.mesh	Female
dc.subject.mesh	Health Services, Indigenous
dc.subject.mesh	Humans
dc.subject.mesh	Kaplan-Meier Estimate
dc.subject.mesh	Male
dc.subject.mesh	Northern Territory
dc.subject.mesh	Proportional Hazards Models
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Scabies
dc.subject.mesh	Tea Tree Oil
dc.subject.mesh	Treatment Outcome
dc.title	Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children: protocol for a randomised controlled trial.
dc.type	Journal Article
utslib.citation.volume	8
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/Faculty of Health/Public Health
utslib.copyright.status	open_access	*
dc.date.updated	2024-03-05T23:28:20Z
pubs.issue	5
pubs.publication-status	Published online
pubs.volume	8
utslib.citation.issue	5

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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