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

NCT ID: NCT01615913

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-06-30

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3% terbinafine patch

A 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole

Group Type: EXPERIMENTAL

3 mg terbinafine and 2 mg ketoconazole containing patch

Intervention Type: DRUG

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.

6% terbinafine patch

A 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole

Group Type: EXPERIMENTAL

6 mg terbinafine and 2 mg ketoconazole containing patch

Intervention Type: DRUG

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.

8% terbinafine patch

A 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole

Group Type: EXPERIMENTAL

8 mg terbinafine and 2 mg ketoconazole containing patch

Intervention Type: DRUG

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.

Interventions

3 mg terbinafine and 2 mg ketoconazole containing patch

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

6 mg terbinafine and 2 mg ketoconazole containing patch

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

8 mg terbinafine and 2 mg ketoconazole containing patch

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiwan Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Mei-Fang Wen

Role: CONTACT

985146@h.tmu.edu.tw

886-2-2737-2181 ext. 3925

Other Identifiers

TE9512

Identifier Type: -

Identifier Source: org_study_id