Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis
NCT ID: NCT01080079
Last Updated: 2012-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2010-05-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A -Terbinafine HCl
Terbinafine HCl
Terbinafine Hydrochloride
4% w/w Terbinafine Hydrochloride Gel
Group B - Terbinafine HCl
Terbinafine HCl
Terbinafine Hydrochloride
4% w/w Terbinafine Hydrochloride Gel
Group C - Terbinafine HCl
Terbinafine HCl
Terbinafine Hydrochloride
4% w/w Terbinafine Hydrochloride Gel
Group D Terbinafine HCl
Terbinafine HCl
Terbinafine Hydrochloride
4% w/w Terbinafine Hydrochloride Gel
Group E
Terbinafine HCl
Terbinafine Hydrochloride
4% w/w Terbinafine Hydrochloride Gel
Group F - Placebo
Placebo application
Purified Water
Purified Water
Interventions
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Terbinafine Hydrochloride
4% w/w Terbinafine Hydrochloride Gel
Purified Water
Purified Water
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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®).
Exclusion Criteria
* 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
* 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.
18 Years
69 Years
ALL
Yes
Sponsors
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Nitric BioTherapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
International Clinical Research, LLC
Sanford, Florida, United States
Gwinnett Clinical Research Center, Inc
Snellville, Georgia, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Temple University Schoool of Podiatric Medicine
Philadelphia, Pennsylvania, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Mediprobe Research, Inc
London, Ontario, Canada
Lynderm Research, Inc
Markham, Ontario, Canada
Countries
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Other Identifiers
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CTP-9
Identifier Type: -
Identifier Source: org_study_id