- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615913
Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
June 6, 2012 updated by: Taiwan Biotech Co., Ltd.
Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine and Ketoconazole Formulation
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mei-Fang Wen
- Phone Number: 3925 886-2-2737-2181
- Email: 985146@h.tmu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 110
- Recruiting
- Taipei Medical University Hospital
-
Principal Investigator:
- Woan-Ruoh Lee, MD
-
Sub-Investigator:
- Hsiou-Hsin Tsai, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3% terbinafine patch
A 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole
|
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.
|
Experimental: 6% terbinafine patch
A 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole
|
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.
|
Experimental: 8% terbinafine patch
A 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presented by pharmacokinetic data (drug plasma concentrations vs. time) or drug deposit amounts in feet nails.
Time Frame: baseline, 8-week, 16-week and 24-week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(1) Efficacy is evaluated 24 weeks after the start of treatment and will be recorded at baseline, 8-week, 16-week and 24-week.
Time Frame: baseline, 8-week, 16-week and 24-week
|
The degrees of improvement are assessed based on each toenail as follows:
|
baseline, 8-week, 16-week and 24-week
|
(2) Safety Monitoring
Time Frame: baseline, 8-week, 16-week and 24-week
|
Adverse events, both local and systemic, will be recorded and their relation to the trial drugs is judged.
|
baseline, 8-week, 16-week and 24-week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Anticipated)
June 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
June 4, 2012
First Submitted That Met QC Criteria
June 6, 2012
First Posted (Estimate)
June 11, 2012
Study Record Updates
Last Update Posted (Estimate)
June 11, 2012
Last Update Submitted That Met QC Criteria
June 6, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Tinea
- Dermatomycoses
- Nail Diseases
- Onychomycosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Ketoconazole
- Terbinafine
Other Study ID Numbers
- TE9512
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Onychomycosis
-
Vésale HospitalJanssen-Cilag Ltd.CompletedPrevalence of Onychomycosis | Diabetic Neuropathic Patients | Diagnostic of Onychomycosis | Patients Clinically Suspected of Onychomycosis | Reliability of the Diagnosis of OnychomycosisBelgium
-
University of Alabama at BirminghamDUSA Pharmaceuticals, Inc.CompletedToenail Onychomycosis | Distal and Lateral Subungual Toenail OnychomycosisUnited States
-
DeviceFarm, Inc.Symbio, LLC; Center for Dermatology Clinical Research, Inc.CompletedOnychomycosis Due to Trichophyton Rubrum | Onychomycosis Due to Trichophyton MentagrophytesUnited States
-
Janssen Korea, Ltd., KoreaCompleted
-
ToeFX Inc.Active, not recruiting
-
SATO Pharmaceutical Co., Ltd.Active, not recruitingOnychomycosis of ToenailUnited States
-
Mahidol UniversityCompletedNon-dermatophyte OnychomycosisThailand
-
Oystershell NVCompletedOnychomycosis of ToenailTunisia
-
Moberg Pharma ABCompletedDistal Subungual OnychomycosisUnited States, Canada
-
PfizerCompletedOnychomycosis of ToenailsUnited States, Canada
Clinical Trials on 3 mg terbinafine and 2 mg ketoconazole containing patch
-
Serum Institute of India Pvt. Ltd.PPDCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
Mylan Pharmaceuticals IncCompleted
-
Mylan Pharmaceuticals IncCompletedHealthyUnited States
-
Medical College of WisconsinCompletedRelapsed Adult AMLUnited States
-
H. Lundbeck A/STerminatedSchizophreniaBulgaria, Czechia, Estonia, Germany, Hungary, Latvia, Poland, Ukraine
-
Johns Hopkins UniversityCompletedPreterm Birth | Bacteremia | Preterm Labor | Preterm Premature Rupture of Fetal MembranesUnited States
-
Otsuka Pharmaceutical Co., Ltd.TerminatedAgitation Associated With Dementia of the Alzheimer's TypeJapan
-
Dr. Reddy's Laboratories LimitedCompleted
-
Natrogen Therapeutics International, IncUnknownUlcerative ColitisUnited States