A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis
Recruitment status was: Recruiting
Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and has the potential to be a source of morbidity. Although oral antifungal agents achieve a better complete cure rate for onychomycosis, many patients are worried about the side effects and unwilling to take oral medications. Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress oil with BioEqual carrier system. A preliminary trial has shown a 100% KOH negative rate in 32 nails after 12 weeks of Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials for the treatment of toenail onychomycosis.
Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail lacquer in the treatment of toenail onychomycosis.
Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1 ratio to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before randomization, patients are to have onychomycosis in at least one great toenail with positive KOH examination and positive fungal culture. During the treatment phase, Phytonail will be applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all affected toenails. Physician's assessments and photographic analyses will be carried out at baseline, Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be performed at baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and for KOH negative patients.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis|
- Mycological cure [ Time Frame: At week 16 ]The primary efficacy endpoint of the study is the mycological cure rate of the target great toenail at Week 16. Mycological cure is defined as both negative KOH and negative fungal culture.
- The treatment success rate of the target toenail [ Time Frame: At Week16 and Week 24. ]Treatment success is defined as both almost clear nail (<10% nail involvement) after proper trimming, as determined by the investigator, and negative KOH and negative fungal culture.
- The complete cure rate of the target toenail [ Time Frame: At Week 16 and Week 24 ]Complete cure is defined as both completely clear nail (0% nail involvement) after proper trimming, as determined by the investigator, and negative KOH and negative fungal culture.
- The CNG (clear nail growth) of the target great toenail [ Time Frame: Week 16 and Week 24 ]For other toenail excluding the target toenail, the proportion of nails that are completely clear (0% nail involvement) or almost clear (<10% nail involvement) at Baseline, Week 16 and Week 24.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Phytonail
Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress (ABC) oil with BioEqual carrier system.
Other Name: herbal ingredients combined with a carrier system (Phytonail)
Active Comparator: amorolfine 5% nail lacquer
Other Name: amorolfine 5% nail lacquer (Loceryl)
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01929187
|Contact: shiu-lan Wang, Masteremail@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Chiu-Nun Chen +886+2-23562141 firstname.lastname@example.org|
|Principal Investigator: Jin-Bon Hong, MD|
|Principal Investigator:||Jin-Bon Hong, MD||Department of Dermatology, National Taiwan University Hospital|