Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 11, 2012
June 1, 2012
1.2 years
June 4, 2012
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline, 8-week, 16-week and 24-week
Secondary Outcomes (2)
(1) Efficacy is evaluated 24 weeks after the start of treatment and will be recorded at baseline, 8-week, 16-week and 24-week.
baseline, 8-week, 16-week and 24-week
(2) Safety Monitoring
baseline, 8-week, 16-week and 24-week
Study Arms (3)
3% terbinafine patch
EXPERIMENTALA 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole
6% terbinafine patch
EXPERIMENTALA 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole
8% terbinafine patch
EXPERIMENTALA 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University Hospital
Taipei, Taiwan, 110, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 11, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 11, 2012
Record last verified: 2012-06