Back to resultsOptimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
3 mg terbinafine and 2 mg ketoconazole containing patch
6 mg terbinafine and 2 mg ketoconazole containing patch
8 mg terbinafine and 2 mg ketoconazole containing patch
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring onychomycosis, terbinafine, ketoconazole, transdermal topical therapy
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
3% terbinafine patch
6% terbinafine patch
8% terbinafine patch
Arm Description
A 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole
A 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole
A 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole
Outcomes
Primary Outcome Measures
Presented by pharmacokinetic data (drug plasma concentrations vs. time) or drug deposit amounts in feet nails.
Both terbinafine and ketoconazole plasma concentration, and their residual contents in toenails will be measured with a validated LC/MS-MS method.
Secondary Outcome Measures
(1) Efficacy is evaluated 24 weeks after the start of treatment and will be recorded at baseline, 8-week, 16-week and 24-week.
The degrees of improvement are assessed based on each toenail as follows:
Complete cure is defined as regeneration of a healthy nail plate to replace the diseased nail.
Marked improvement is defined as regeneration of a healthy nail plate in at least 70% of the affected nail.
Improvement is defined as regeneration in 40-70% of the affected nail.
Slight improvement is defined as regeneration in less than 40%.
No change is defined as the absence of change or exacerbation of the disease condition or the side effect.
(2) Safety Monitoring
Adverse events, both local and systemic, will be recorded and their relation to the trial drugs is judged.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01615913
Brief Title
Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
Official Title
Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine and Ketoconazole Formulation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Biotech Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
onychomycosis, terbinafine, ketoconazole, transdermal topical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3% terbinafine patch
Arm Type
Experimental
Arm Description
A 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole
Arm Title
6% terbinafine patch
Arm Type
Experimental
Arm Description
A 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole
Arm Title
8% terbinafine patch
Arm Type
Experimental
Arm Description
A 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole
Intervention Type
Drug
Intervention Name(s)
3 mg terbinafine and 2 mg ketoconazole containing patch
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
6 mg terbinafine and 2 mg ketoconazole containing patch
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
8 mg terbinafine and 2 mg ketoconazole containing patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presented by pharmacokinetic data (drug plasma concentrations vs. time) or drug deposit amounts in feet nails.
Description
Both terbinafine and ketoconazole plasma concentration, and their residual contents in toenails will be measured with a validated LC/MS-MS method.
Time Frame
baseline, 8-week, 16-week and 24-week
Secondary Outcome Measure Information:
Title
(1) Efficacy is evaluated 24 weeks after the start of treatment and will be recorded at baseline, 8-week, 16-week and 24-week.
Description
The degrees of improvement are assessed based on each toenail as follows:
Complete cure is defined as regeneration of a healthy nail plate to replace the diseased nail.
Marked improvement is defined as regeneration of a healthy nail plate in at least 70% of the affected nail.
Improvement is defined as regeneration in 40-70% of the affected nail.
Slight improvement is defined as regeneration in less than 40%.
No change is defined as the absence of change or exacerbation of the disease condition or the side effect.
Time Frame
baseline, 8-week, 16-week and 24-week
Title
(2) Safety Monitoring
Description
Adverse events, both local and systemic, will be recorded and their relation to the trial drugs is judged.
Time Frame
baseline, 8-week, 16-week and 24-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-Fang Wen
Phone
886-2-2737-2181
Ext
3925
Email
985146@h.tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woan-Ruoh Lee, MD
First Name & Middle Initial & Last Name & Degree
Hsiou-Hsin Tsai, MD
12. IPD Sharing Statement
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Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
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