Treatment of tungiasis using a tea tree oil-based gel formulation: protocol for a randomised controlled proof-of-principle trial.

complementary medicine dermatology infectious diseases infectious diseases & infestations paediatric dermatology

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
29 07 2021
Historique:
entrez: 30 7 2021
pubmed: 31 7 2021
medline: 5 8 2021
Statut: epublish

Résumé

Tungiasis (sand flea disease or jigger infestation) is a neglected tropical disease caused by penetration of female sand fleas, This trial is a randomised controlled trial (RCT) in primary schools (n=8) in South-Western Kenya. The study will include school children (n=88) aged 6-15 years with a confirmed diagnosis of tungiasis. The participants will be randomised in a 1:1 ratio to receive a 3-day two times a day treatment of either 5% TTO gel or 0.05% KMnO The trial protocol has been reviewed and approved by the University of Canberra Human Research Ethics Committee (HREC-2019-2114). The findings of the study will be presented at scientific conferences and published in a peer-reviewed journal. Australian New Zealand Clinical Trials Registry (ACTRN12619001610123); PACTR202003651095100 and U1111-1243-2294.

Identifiants

pubmed: 34326048
pii: bmjopen-2020-047380
doi: 10.1136/bmjopen-2020-047380
pmc: PMC8323357
doi:

Substances chimiques

Tea Tree Oil 68647-73-4

Banques de données

ANZCTR
['ACTRN12619001610123']
PACTR
['PACTR202003651095100']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e047380

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Solomon Abrha (S)

Pharmacy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia.
Department of Pharmaceutics, Mekelle University, Mekelle, Tigray, Ethiopia.

Julia K Christenson (JK)

Pharmacy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia.

John McEwen (J)

Pharmacy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia.

Wubshet Tesfaye (W)

Pharmacy, Health Research Institute, University of Canberra, Canberra, Australian Capital Territory, Australia.

Susana Vaz Nery (S)

The Public Health Interventions Research Program, The Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, New South Wales, Australia.

Aileen Y Chang (AY)

Department of Dermatology, University of California San Francisco, San Francisco, California, USA.

Tim Spelman (T)

Public Health, Burnet Institute International Health Research Group, Melbourne, Victoria, Australia.

Sam Kosari (S)

Pharmacy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia.

Gabriel Kigen (G)

Department of Pharmacology and Toxicology, Moi University School of Medicine, Eldoret, Central, Kenya.

Simon Carroll (S)

Pharmacy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia.
Global School Partners, Canberra, Australian Capital Territory, Australia.

Jorg Heukelbach (J)

Department of Community Health, Federal University of Ceará, Fortaleza, Brazil, Fortaleza, Brazil.

Hermann Feldmeier (H)

Institute of Microbiology and Infection Immunology, Campus Benjamin Franklin, Charité University Medicine, Berlin, Germany.

Andrew Bartholomaeus (A)

Diamantina Institute, The University of Queensland, Woolloongabba, Queensland, Australia.

Mark Daniel (M)

Centre for Research and Action in Public Health, Health Research Institute, University of Canberra, Canberra, Australian Capital Territory, Australia.

Gregory M Peterson (GM)

School of Pharmacy, University of Tasmania, Hobart, Tasmania, Australia.

Jackson Thomas (J)

Pharmacy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia Jackson.Thomas@canberra.edu.au.

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