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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01080079
First received: March 1, 2010
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Onychomycosis
Drug: Terbinafine Hydrochloride
Other: Purified Water
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • Clinical and Microbiological Improvement in nails vs placebo [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: May 2010
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080079

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

No publications provided

Responsible Party: Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier: NCT01080079     History of Changes
Other Study ID Numbers: CTP-9
Study First Received: March 1, 2010
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014