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

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080079
• Other study ID #: CTP-9
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2010
• Last updated: October 18, 2012
• Start date: May 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Nitric BioTherapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• Terbinafine Hydrochloride
4% w/w Terbinafine Hydrochloride Gel

Other:
• Purified Water
Purified Water

Locations

Country	Name	City	State
Canada	Mediprobe Research, Inc	London	Ontario
Canada	Lynderm Research, Inc	Markham	Ontario
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Temple University Schoool of Podiatric Medicine	Philadelphia	Pennsylvania
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	International Clinical Research, LLC	Sanford	Florida
United States	Gwinnett Clinical Research Center, Inc	Snellville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Nitric BioTherapeutics, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and Microbiological Improvement in nails vs placebo		11 months	No