Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis

• ClinicalTrials.gov Identifier: NCT01080079
• Recruitment Status: Completed
• First Posted: March 3, 2010
• Last Update Posted: October 19, 2012
• Sponsor: Nitric BioTherapeutics, Inc
• Information provided by (Responsible Party): Nitric BioTherapeutics, Inc

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Onychomycosis	Drug: Terbinafine Hydrochloride; Other: Purified Water	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 2010
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group A -Terbinafine HCl; Terbinafine HCl	Drug: Terbinafine Hydrochloride; 4% w/w Terbinafine Hydrochloride Gel
Active Comparator: Group B - Terbinafine HCl; Terbinafine HCl	Drug: Terbinafine Hydrochloride; 4% w/w Terbinafine Hydrochloride Gel
Active Comparator: Group C - Terbinafine HCl; Terbinafine HCl	Drug: Terbinafine Hydrochloride; 4% w/w Terbinafine Hydrochloride Gel
Active Comparator: Group D Terbinafine HCl; Terbinafine HCl	Drug: Terbinafine Hydrochloride; 4% w/w Terbinafine Hydrochloride Gel
Active Comparator: Group E; Terbinafine HCl	Drug: Terbinafine Hydrochloride; 4% w/w Terbinafine Hydrochloride Gel
Placebo Comparator: Group F - Placebo; Placebo application	Other: Purified Water; Purified Water

Outcome Measures

Primary Outcome Measures :

1. Clinical and Microbiological Improvement in nails vs placebo [ Time Frame: 11 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

- • 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.
• 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:

- • 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
• 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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

United States, Florida

International Clinical Research, LLC

Sanford, Florida, United States, 32771

United States, Georgia

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, United States, 30078

United States, Oregon

Oregon Dermatology and Research Center

Portland, Oregon, United States, 97210

United States, Pennsylvania

Temple University Schoool of Podiatric Medicine

Philadelphia, Pennsylvania, United States, 19107

United States, Tennessee

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215

United States, Texas

Endeavor Clinical Trials, PA

San Antonio, Texas, United States, 78229

Canada, Ontario

Mediprobe Research, Inc

London, Ontario, Canada, N5X 2P1

Lynderm Research, Inc

Markham, Ontario, Canada, L3P 1A8

Sponsors and Collaborators

Nitric BioTherapeutics, Inc

More Information

• Responsible Party: Nitric BioTherapeutics, Inc
• ClinicalTrials.gov Identifier: NCT01080079
• Other Study ID Numbers: CTP-9
• First Posted: March 3, 2010
• Last Update Posted: October 19, 2012
• Last Verified: October 2012

Keywords provided by Nitric BioTherapeutics, Inc:

Onychomycosis

Additional relevant MeSH terms:

Onychomycosis; Tinea; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Nail Diseases; Skin Diseases; Terbinafine; Antifungal Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action