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Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole

Onychomycosis Clinical Trial

Official title:
Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine and Ketoconazole Formulation

Clinical Trial Summary

This study is to explore the optimization of anti‐onychomycosis patch with various formulation contents (three patch groups: 3%, 6% and 8% of terbinafine (contains 3‐mg, 6‐mg and 8‐mg/patch terbinafine, respectively) combined with fixed 2% ketoconazole (contains 2‐mg ketoconazole/patch) and its safety profile.

Clinical Trial Description

This study is to explore the optimization of anti‐onychomycosis patch with various formulation contents (three patch groups: 3%, 6% and 8% of terbinafine (contains 3‐mg, 6‐mg and 8‐mg/patch terbinafine, respectively) combined with fixed 2% ketoconazole (contains 2‐mg ketoconazole/patch) and its safety profile. At least 18 patients (age: 20 to 75 years old) with one or two feet toenails infected simultaneously need to complete the whole study. Patients will be assigned to one of patch groups. The patients with only one infected toenail will also apply one patch on other foot with uninfected toenail. The patch will be applied on the foot on the dorsal site and leave it there for two consecutive days. Totally six patches will be used for each week. The duration of therapy will be 24 weeks. The patients' blood sample and toenail clippings will be collected every 8 weeks and will be analyzed as well as the safety profiles. The most appropriate patch formulation will be selected on the drug content residues in toenail. The safety profile will be also presented and discussed with various anti‐onychomycosis patch formulations. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01615913
Study type Interventional
Source Taiwan Biotech Co., Ltd.
Contact Mei-Fang Wen
Phone 886-2-2737-2181
Email 985146@h.tmu.edu.tw
Status Recruiting
Phase Phase 1
Start date April 2012
Completion date June 2013
View Details
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