None listed
Conditions
Brief 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).
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%; 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
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.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
The main exclusion criteria were other nail conditions (psoriasis, bacterial infections, contact dermatitis, nail bed tumours, yellow nail syndrome, traumatic onychodystrophies, lichen planus, pachonychia congenita and idiopathic onycholysis ) confounding onychomycosis assessment, pregnancy, breast-feeding, and a known history of allergy to essential oils. All patients had a 6-week washout period for systemic antifungal therapy and 4 weeks for topical antifungal treatment prior to receiving the study drugs
Outcome results
None listed