OnychomycosisPhase 1NCT01615913
Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
A Phase 1 study testing 3 mg terbinafine and 2 mg ketoconazole containing patch, 6 mg terbinafine and 2 mg ketoconazole containing patch and 8 mg terbinafine and 2 mg ketoconazole containing patch in people with Onychomycosis, run by Taiwan Biotech Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- 3 mg terbinafine and 2 mg ketoconazole containing patch, 6 mg terbinafine and 2 mg ketoconazole containing patch and 8 mg terbinafine and 2 mg ketoconazole containing patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, Taiwan, 110
Woan-Ruoh Lee, MD
Hsiou-Hsin Tsai, MD
About this study
Official title: 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.
Read the 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
- Being tested
- 3 mg terbinafine and 2 mg ketoconazole containing patch, 6 mg terbinafine and 2 mg ketoconazole containing patch, 8 mg terbinafine and 2 mg ketoconazole containing patch
- Keywords
- onychomycosis, terbinafine, ketoconazole, transdermal topical therapy
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mg terbinafine and 2 mg ketoconazole containing patchDrug
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 mg terbinafine and 2 mg ketoconazole containing patchDrug
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 mg terbinafine and 2 mg ketoconazole containing patchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 3% terbinafine patch | Experimental | A 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole Receives: Drug: 3 mg terbinafine and 2 mg ketoconazole containing patch |
| 6% terbinafine patch | Experimental | A 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole Receives: Drug: 6 mg terbinafine and 2 mg ketoconazole containing patch |
| 8% terbinafine patch | Experimental | A 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole Receives: Drug: 8 mg terbinafine and 2 mg ketoconazole containing patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The degrees of improvement are assessed based on each toenail as follows:
- Complete cure is defined as regeneration of a healthy nail plate to replace the diseased nail.
- Marked improvement is defined as regeneration of a healthy nail plate in at least 70% of the affected nail.
- Improvement is defined as regeneration in 40-70% of the affected nail.
- Slight improvement is defined as regeneration in less than 40%.
- No change is defined as the absence of change or exacerbation of the disease condition or the side effect.
Measured: baseline, 8-week, 16-week and 24-week
(2) Safety Monitoring
Adverse events, both local and systemic, will be recorded and their relation to the trial drugs is judged.
Measured: baseline, 8-week, 16-week and 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615913
- Sponsor's protocol ID
- TE9512
- Status last verified
- Jun 2012
- First submitted
- 4 Jun 2012
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine and Ketoconazole Formulation
- ClinicalTrials.gov ID
- NCT01615913
- Acronym / sponsor ID
- TE9512
- Conditions
- Onychomycosis
- Keywords
- onychomycosis, terbinafine, ketoconazole, transdermal topical therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Taiwan Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3% terbinafine patch | Experimental | Drug: 3 mg terbinafine and 2 mg ketoconazole containing patchA 10-cm2 patch containing 3 mg terbinafine and 2 mg ketoconazole |
| 6% terbinafine patch | Experimental | Drug: 6 mg terbinafine and 2 mg ketoconazole containing patchA 10-cm2 patch containing 6 mg terbinafine and 2 mg ketoconazole |
| 8% terbinafine patch | Experimental | Drug: 8 mg terbinafine and 2 mg ketoconazole containing patchA 10-cm2 patch containing 8 mg terbinafine and 2 mg ketoconazole |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 mg terbinafine and 2 mg ketoconazole containing patchA 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. | Drug | 3% terbinafine patch |
| 6 mg terbinafine and 2 mg ketoconazole containing patchA 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. | Drug | 6% terbinafine patch |
| 8 mg terbinafine and 2 mg ketoconazole containing patchA 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. | Drug | 8% terbinafine patch |
Primary outcome
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.
2 secondary outcomes
(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
(2) Safety Monitoring
Time frame: baseline, 8-week, 16-week and 24-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3 mg terbinafine and 2 mg ketoconazole containing patch, 6 mg terbinafine and 2 mg ketoconazole containing patch and 8 mg terbinafine and 2 mg ketoconazole containing patch in people with Onychomycosis, run by Taiwan Biotech Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Fang Wen (886-2-2737-2181 ext. 3925, 985146@h.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.