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

June 6, 2012 updated by: Taiwan Biotech Co., Ltd.

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

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.

Study Overview

Detailed 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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital
        • Principal Investigator:
          • Woan-Ruoh Lee, MD
        • Sub-Investigator:
          • Hsiou-Hsin Tsai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and females 20-75 years of age
  • Fungal infection of one or both toenails will be confirmed using the method of histopathological examination with periodic acid-Schiff (PAS) staining (Yang JH, et al., 2007)
  • The toenail infection can be due to a dermatophyte, yeast or mixed infections (dermatophyte and non-dermatophyte)
  • The target toenail area must have at least 25% to no more than 75% disease involvement without spikes
  • Patients agree to sign the informed consent form

Exclusion Criteria:

  • Using any kind of systemic or topical nail lacquer solution antifungal drugs within 6 months before at screening visit; or using any other topical antifungal agents, such as ointment, cream, gel, solution, suspension, oil or lotion forms, within two weeks before at screening visits
  • Patients with the target toenail involving the matrix (lunula) or having less than 2 mm clear (unaffected) nail plate length beyond the proximal fold
  • Presence of dermatophytoma on the target nail
  • Using professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
  • Patients who are unwilling to provide nail clippings
  • Patients who have been previously reported to be allergic to topical or systemic terbinafine or ketoconazole therapy or both
  • Known pregnancy or plan to get pregnant within study duration or lactation at time of enrollment
  • Unconsciousness or inability to understand this form or this study project.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3% terbinafine patch
A 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole
A novel transdermal patch that is to be used to treat toenail onychomycosis with minimal body exposure to the antifungal drugs. The active substances in the patch are 3% terbinafine (contains 3-mg terbinafine/patch) and 2% ketoconazole (contains 2-mg ketoconazole/patch). The average daily released drug amount estimated from in-vitro skin permeation test were about 3.99 mcg for terbinafine and 1.70 mcg for ketoconazole, respectively.
Experimental: 6% terbinafine patch
A 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole
A novel transdermal patch that is to be used to treat toenail onychomycosis with minimal body exposure to the antifungal drugs. The active substances in the patch are 6% terbinafine (contains 6-mg terbinafine/patch) and 2% ketoconazole (contains 2-mg ketoconazole/patch). The average daily released drug amount estimated from in-vitro skin permeation test were about 8.52 mcg for terbinafine and 2.03 mcg for ketoconazole, respectively.
Experimental: 8% terbinafine patch
A 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole
A novel transdermal patch that is to be used to treat toenail onychomycosis with minimal body exposure to the antifungal drugs. The active substances in the patch are 8% terbinafine (contains 8-mg terbinafine/patch) and 2% ketoconazole (contains 2-mg ketoconazole/patch). The average daily released drug amount estimated from in-vitro skin permeation test were about 10.7 mcg for terbinafine and 2.17 mcg for ketoconazole, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presented by pharmacokinetic data (drug plasma concentrations vs. time) or drug deposit amounts in feet nails.
Time Frame: baseline, 8-week, 16-week and 24-week
Both terbinafine and ketoconazole plasma concentration, and their residual contents in toenails will be measured with a validated LC/MS-MS method.
baseline, 8-week, 16-week and 24-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(1) Efficacy is evaluated 24 weeks after the start of treatment and will be recorded at baseline, 8-week, 16-week and 24-week.
Time Frame: baseline, 8-week, 16-week and 24-week

The degrees of improvement are assessed based on each toenail as follows:

  1. Complete cure is defined as regeneration of a healthy nail plate to replace the diseased nail.
  2. Marked improvement is defined as regeneration of a healthy nail plate in at least 70% of the affected nail.
  3. Improvement is defined as regeneration in 40-70% of the affected nail.
  4. Slight improvement is defined as regeneration in less than 40%.
  5. No change is defined as the absence of change or exacerbation of the disease condition or the side effect.
baseline, 8-week, 16-week and 24-week
(2) Safety Monitoring
Time Frame: baseline, 8-week, 16-week and 24-week
Adverse events, both local and systemic, will be recorded and their relation to the trial drugs is judged.
baseline, 8-week, 16-week and 24-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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