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

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Biotech Co., Ltd.
• Treatments: Ketoconazole; Terbinafine

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.