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

Phase 2

Completed

• Conditions: fungal nail infection (toenail onychomycosis); Skin - Dermatological conditions; Alternative and Complementary Medicine - Other alternative and complementary medicine; Infection - Other infectious diseases

• Registration Number: ACTRN12614000946617
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy variable was mycological cure (negative mycology) at week 40'+/-'2 weeks.<br><br>The primary outcome was assessed by culturing the nail clippings (by following the standard microbiology procedure at Royal Hobart Hospital) collected from patients' target toenails before commencing the therapy and after 40'+/-'2 weeks. [Time-point: at baseline and 40'+/-' 2 weeks after randomisation ]