CompletedPhase 2ACTRN12614000946617

Kunzea oil for the management of fungal nail infection (toenail onychomycosis), a pilot randomised controlled trial.

Evaluation of kunzea oil for the management of toenail onychomycosis with amorolfine lacquer, a pilot randomised, controlled trial.


Sponsor

University of Tasmania

Enrollment

130 participants

Start Date

Aug 21, 2007

Study Type

Interventional

Conditions

Summary

Onychomycosis is a common nail infection. Current topical therapies are largely ineffective, systemic drugs have significant safety risks, and are limited in broader range of patients. A safe, relatively inexpensive, alternative topical treatment is required to minimise treatment failures and relapses, and also as an adjuvant treatment to improve cure rates. The present study compared the efficacy and safety of topical kunzea oil (twice daily) with amorolfine (once weekly) for the management onychomycosis (study duration 40' +/-' 2 weeks). The study recruited patients from single site (Royal Hobart Podiatry).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Entry criteria required a clinical diagnosis of onychomycosis (based on clinical manifestations and positive mycology [mycological culture]) involving less than or equal to 20% of the area of one of the great toenails and a minimum age of 18

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Interventions

Group A [test] received topical test treatment with kunzea oil (twice daily), and group B [control] applied control medication, amorolfine lacquer (weekly) for 40+/-2 weeks. Neat kunzea oil (100%

Group A [test] received topical test treatment with kunzea oil (twice daily), and group B [control] applied control medication, amorolfine lacquer (weekly) for 40+/-2 weeks. Neat kunzea oil (100%; steam distilled and commercially produced in Tasmania from the bush plant Kunzea ambigua), patients were given instructions to apply the oil twice daily (morning and evening) for 40+/- 2 weeks. Compliance:Furthermore, compliance to the treatment protocol was encouraged by bi-monthly telephone calls and letters. Furthermore, the research assistant reminded the subjects of the importance of adhering to the treatment protocol at each of their follow-up visits to the podiatry clinic.


Locations(1)

Royal Hobart Hospital - Hobart

TAS, Australia

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ACTRN12614000946617