OnychomycosisPhase 2NCT01080079
Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis
A Phase 2 study testing Terbinafine Hydrochloride and Purified Water in people with Onychomycosis, run by Nitric BioTherapeutics, Inc at 9 sites in 2 countries.
Trial summary
The purpose of this study is to determine if the iontophoretic application of terbinafine gel is safe and effective for teh treatment of distal subungual onychomycosis Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Terbinafine Hydrochloride and Purified Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2010to Jun 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Positive clinical findings for distal subungual onychomycosis as determined by clinical examination
- Must have a great toenail involvement with onychomycosis in ≥25-≤65% of the visible nail. (more than one nail maybe affected however only the index great toenail will be evaluated)
- Nail plate must be ≤ 3 mm thick.
- Must have a positive KOH and positive identification of a Dermatophyte via culture.
- Written informed consent must be obtained from the subject.
- Must be ≥ 18 and < 70 years of age, unless local laws dictate otherwise.
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- 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 the conclusion of the trial.
- Must agree to take measures to avoid pregnancy during the study period
- Must agree to avoid the use of oral or topical antifungals unless provided by the investigator for the relief of symptomatic (active clinical signs) tinea pedis which has occurred during the treatment / follow up phase of the study. (The treatment provided will be Lotrimin®).
Who cannot join
- • The presence of proximal subungual onychomycosis or white superficial onychomycosis
- Fungal involvement of the lunula or less than 2 mm of clear nail from the the proximal nail fold
- Subjects with psoriasis, eczema, symptomatic (with active clinical signs) interdigital or plantar tinea pedis, lichen planus, or other abnormalities (e.g. traumatized or dystrophic nails) that could result in a clinically abnormal nail or the investigator thinks the current condition will compromise the integrity of the trial
- Any presence of dermatophytoma or onychomycotic spikes
- Subjects with either uncontrolled diabetes mellitus or known diabetics on pharmaceutical therapy or those with no palpable pedal pulse
- Subjects with peripheral vascular disease
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- Subjects who are immunosuppressed - those on chronic corticosteroid therapy (see below), with 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 topical antifungals e.g. (clotrimazole, ketoconazole, miconazole, oxiconazole (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, tolnaftate, haloprogin), Zeasorb-AF Ciclopirox (e.g. Penlac® Nail Lacquer, Sanofi-Aventis) and corticosteroids (e.g. hydrocortisone, betamethasone, fluticasone and mometasone) in the preceding 15 days of Day 1, on or immediately around the area under evaluation.
- Use of systemic corticosteroids within 30 days preceding Day 1
- Use of systemic antifungals in the preceding 120 days of Day 1 including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (Gris-PEG®, Pedinol), butoconazole, terconazole, potassium iodide,.
- Has used any investigational drug(s) within 30 days preceding Day 1, with the exception of investigational systemic antifungals (120 days))
- Is pregnant or is a nursing mother
- Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
- Is < 18 years of age, unless local laws dictate otherwise.
- Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data.
- Subjects with a pacemaker or automatic implantable cardioverter/defibrillator.
- Subjects with an implantable electronic device.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Temple University Schoool of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
International Clinical Research, LLC
Sanford, Florida, 32771
Gwinnett Clinical Research Center, Inc
Snellville, Georgia, 30078
Canada2 sites
Mediprobe Research, Inc
London, Ontario, N5X 2P1
Lynderm Research, Inc
Markham, Ontario, L3P 1A8
About this study
Official title: A Subject Blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail
The purpose of this study is to determine if the iontophoretic application of terbinafine gel is safe and effective for teh treatment of distal subungual onychomycosis
- Conditions
- Onychomycosis
- Being tested
- Terbinafine Hydrochloride, Purified Water
- Keywords
- Onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine HydrochlorideDrug
4% w/w Terbinafine Hydrochloride Gel
Purified WaterOther
Purified Water
| Study group | Role | What they receive |
|---|---|---|
| Group A -Terbinafine HCl | Active comparator | Terbinafine HCl Receives: Drug: Terbinafine Hydrochloride |
| Group B - Terbinafine HCl | Active comparator | Terbinafine HCl Receives: Drug: Terbinafine Hydrochloride |
| Group C - Terbinafine HCl | Active comparator | Terbinafine HCl Receives: Drug: Terbinafine Hydrochloride |
| Group D Terbinafine HCl | Active comparator | Terbinafine HCl Receives: Drug: Terbinafine Hydrochloride |
| Group E | Active comparator | Terbinafine HCl Receives: Drug: Terbinafine Hydrochloride |
| Group F - Placebo | Placebo comparator | Placebo application Receives: Other: Purified Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Microbiological Improvement in nails vs placebo
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionJun 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 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
- NCT01080079
- Sponsor's protocol ID
- CTP-9
- Status last verified
- Oct 2012
- First submitted
- 1 Mar 2010
- 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
- A Subject Blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail
- ClinicalTrials.gov ID
- NCT01080079
- Acronym / sponsor ID
- CTP-9
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Mar 2010 (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 if the iontophoretic application of terbinafine gel is safe and effective for teh treatment of distal subungual onychomycosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A -Terbinafine HCl | Active comparator | Drug: Terbinafine HydrochlorideTerbinafine HCl |
| Group B - Terbinafine HCl | Active comparator | Drug: Terbinafine HydrochlorideTerbinafine HCl |
| Group C - Terbinafine HCl | Active comparator | Drug: Terbinafine HydrochlorideTerbinafine HCl |
| Group D Terbinafine HCl | Active comparator | Drug: Terbinafine HydrochlorideTerbinafine HCl |
| Group E | Active comparator | Drug: Terbinafine HydrochlorideTerbinafine HCl |
| Group F - Placebo | Placebo comparator | Other: Purified WaterPlacebo application |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Positive clinical findings for distal subungual onychomycosis as determined by clinical examination
- Must have a great toenail involvement with onychomycosis in ≥25-≤65% of the visible nail. (more than one nail maybe affected however only the index great toenail will be evaluated)
- Nail plate must be ≤ 3 mm thick.
- Must have a positive KOH and positive identification of a Dermatophyte via culture.
- Written informed consent must be obtained from the subject.
Key exclusion criteria (17 listed)
- • The presence of proximal subungual onychomycosis or white superficial onychomycosis
- Fungal involvement of the lunula or less than 2 mm of clear nail from the the proximal nail fold
- Subjects with psoriasis, eczema, symptomatic (with active clinical signs) interdigital or plantar tinea pedis, lichen planus, or other abnormalities (e.g. traumatized or dystrophic nails) that could result in a clinically abnormal nail or the investigator thinks the current condition will compromise the integrity of the trial
- Any presence of dermatophytoma or onychomycotic spikes
- Subjects with either uncontrolled diabetes mellitus or known diabetics on pharmaceutical therapy or those with no palpable pedal pulse
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 Hydrochloride4% w/w Terbinafine Hydrochloride Gel | Drug | Group A -Terbinafine HCl, Group B - Terbinafine HCl, Group C - Terbinafine HCl, Group D Terbinafine HCl, Group E |
| Purified WaterPurified Water | Other | Group F - Placebo |
Primary outcome
Clinical and Microbiological Improvement in nails vs placebo
Time frame: 11 months
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.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terbinafine Hydrochloride and Purified Water in people with Onychomycosis, run by Nitric BioTherapeutics, Inc at 9 sites in 2 countries.
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 9 inclusion and 17 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 9 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Clinical and Microbiological Improvement in nails vs placebo (time frame: 11 months). 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; AzTrials last refreshed its copy on 8 Nov 2026.