OnychomycosisPhase 2NCT01484145
Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail
A Phase 2 study testing Terbinafine HCl in people with Onychomycosis, run by Nitric BioTherapeutics, Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine how much terbinafine is delivered to the nail bed after treatment with a number of modifications to a previously studied method for iontophoretic delivery of terbinafine gel. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Terbinafine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2012
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive KOH
- 25-75% involvement of the visible nail.
- Nail plate must be < 3 mm thick.
- Must have signed informed consent.
- Must agree to avoid any type of pedicure or application of any nail polish product or nail cosmetic to the toenails after the screening visit until Day 28.
- Female subjects of childbearing potential must agree to take measures to avoid pregnancy until the day after Day 28
- Must agree to avoid the use of oral antifungals or topical terbinafine anywhere on the body until the day after Day 28. Topical antifungals other than terbinafine can be used on the body other than the feet after Day 0.
Who cannot join
- Presence of proximal subungual onychomycosis or white superficial onychomycosis
- Fungal involvement of a majority of the lunula
- Subjects with psoriasis, eczema, or other abnormalities that could result in a clinically abnormal nail
- Presence of dermatophytoma or onychomycotic spikes or exclusively lateral groove involvement
- Traumatized or dystrophic target great toenail.
- Known diabetics
Show all 19Show fewer
- Subjects with peripheral vascular disease
- Subjects who are immunosuppressed (chronic corticosteroid therapy, solid organ or bone marrow transplantation, cytotoxic chemotherapy within the previous 12 months (or planned within the next 12 months), or HIV infection.
- Use of systemic corticosteroids within 30 days preceding Day 0
- Use of topical antifungals on the feet in the preceding 30 days of Day 0 through Day 28
- Use of topical terbinafine in the 30 days prior to treatment through Day 28
- Use of systemic antifungals in the preceding 120 days of Day 0 through Day 28
- Use of any investigational drug(s) within 30 days (120 days for systemic antifungals) preceding Day 0 through Day 28
- Has previously participated in this study
- Is pregnant or is a nursing mother
- Women of of child bearing potential who are not using an adequate form of contraception (or abstinence)
- Subjects with pacemakers/automatic implantable cardioverter/defibrillators
- Subjects with an implantable electronic device.
- Subjects with a bleeding disorder or who are using warfarin or any other blood coagulation modulator including aspirin in the 14 days prior to treatment through Day 28
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Unblinded Clinical Trial to Evaluate the Deposition of Terbinafine in the Nail Bed After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail
The purpose of this study is to determine how much terbinafine is delivered to the nail bed after treatment with a number of modifications to a previously studied method for iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small electric charge to deliver drug across skin and nails.
- Conditions
- Onychomycosis
- Being tested
- Terbinafine HCl
- Keywords
- Onychomycosis, Nail fungus, Tinea Unguium
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine HClDrug
4% w/w terbinafine HCL gel, single dose,
| Study group | Role | What they receive |
|---|---|---|
| 6 mA.min, 20 mins | Active comparator | Not described Receives: Drug: Terbinafine HCl |
| 6 mA/min, 20 mins, clamping | Experimental | Not described Receives: Drug: Terbinafine HCl |
| 6 mA/min, 20 mins, debridement, clamping | Experimental | Not described Receives: Drug: Terbinafine HCl |
| 15 mA/min, 30 mins, clamping | Experimental | Not described Receives: Drug: Terbinafine HCl |
| 15 mA/min, 50 mins, debridement, clamping | Experimental | Not described Receives: Drug: Terbinafine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of terbinafine in the nail bed (ng/mg)
Measured: Day 28
Plasma terbinafine levels (ng/ml)
Measured: Day 28
Secondary outcomes (1)
Number of treatment emergent adverse events (AEs)& Serious Adverse Events (SAEs)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionApr 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitric BioTherapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484145
- Sponsor's protocol ID
- CTP-10
- Status last verified
- Oct 2012
- First submitted
- 28 Nov 2011
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Unblinded Clinical Trial to Evaluate the Deposition of Terbinafine in the Nail Bed After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail
- ClinicalTrials.gov ID
- NCT01484145
- Acronym / sponsor ID
- CTP-10
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Nail fungus, Tinea Unguium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 2 Dec 2011 (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.
The purpose of this study is to determine how much terbinafine is delivered to the nail bed after treatment with a number of modifications to a previously studied method for iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small electric charge to deliver drug across skin and nails.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 6 mA.min, 20 mins | Active comparator | Drug: Terbinafine HCl |
| 6 mA/min, 20 mins, clamping | Experimental | Drug: Terbinafine HCl |
| 6 mA/min, 20 mins, debridement, clamping | Experimental | Drug: Terbinafine HCl |
| 15 mA/min, 30 mins, clamping | Experimental | Drug: Terbinafine HCl |
| 15 mA/min, 50 mins, debridement, clamping | Experimental | Drug: Terbinafine HCl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Positive KOH
- 25-75% involvement of the visible nail.
- Nail plate must be < 3 mm thick.
- Must have signed informed consent.
- Must agree to avoid any type of pedicure or application of any nail polish product or nail cosmetic to the toenails after the screening visit until Day 28.
Key exclusion criteria (19 listed)
- Presence of proximal subungual onychomycosis or white superficial onychomycosis
- Fungal involvement of a majority of the lunula
- Subjects with psoriasis, eczema, or other abnormalities that could result in a clinically abnormal nail
- Presence of dermatophytoma or onychomycotic spikes or exclusively lateral groove involvement
- Traumatized or dystrophic target great toenail.
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 |
|---|---|---|
| Terbinafine HCl4% w/w terbinafine HCL gel, single dose, | Drug | 15 mA/min, 30 mins, clamping, 15 mA/min, 50 mins, debridement, clamping, 6 mA.min, 20 mins, 6 mA/min, 20 mins, clamping, 6 mA/min, 20 mins, debridement, clamping |
Primary outcome
Level of terbinafine in the nail bed (ng/mg)
Time frame: Day 28
Plasma terbinafine levels (ng/ml)
Time frame: Day 28
1 secondary outcome
Number of treatment emergent adverse events (AEs)& Serious Adverse Events (SAEs)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terbinafine HCl in people with Onychomycosis, run by Nitric BioTherapeutics, Inc at 1 site in United States.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 19 Oct 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of terbinafine in the nail bed (ng/mg) (time frame: Day 28). The study lists 2 primary outcomes in all. 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 19 Oct 2012.