Clinical trial NCT01615913: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Onychomycosis
Keywords: onychomycosis
terbinafine
ketoconazole
transdermal topical therapy
Lead sponsor: Taiwan Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-11
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Presented by pharmacokinetic data (drug plasma concentrations vs. time) or drug deposit amounts in feet nails.
timeFrame: baseline, 8-week, 16-week and 24-week
Secondary outcomes:
measure: (1) Efficacy is evaluated 24 weeks after the start of treatment and will be recorded at baseline, 8-week, 16-week and 24-week.
timeFrame: baseline, 8-week, 16-week and 24-week
measure: (2) Safety Monitoring
timeFrame: baseline, 8-week, 16-week and 24-week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: