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

NCT01080079 | Completed Phase 2

• 1 other identifier: CTP-9
• Study Type: interventional
• Target: 168
• Locations: 2 countries
• Sites: 9

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

Conditions

Onychomycosis

Keywords

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Clinical and Microbiological Improvement in nails vs placebo

  11 months

Study Arms (6)

Group A -Terbinafine HCl

ACTIVE COMPARATOR

Terbinafine HCl

Drug: Terbinafine Hydrochloride

Group B - Terbinafine HCl

ACTIVE COMPARATOR

Terbinafine HCl

Drug: Terbinafine Hydrochloride

Group C - Terbinafine HCl

ACTIVE COMPARATOR

Terbinafine HCl

Drug: Terbinafine Hydrochloride

Group D Terbinafine HCl

ACTIVE COMPARATOR

Terbinafine HCl

Drug: Terbinafine Hydrochloride

Group E

ACTIVE COMPARATOR

Terbinafine HCl

Drug: Terbinafine Hydrochloride

Group F - Placebo

PLACEBO COMPARATOR

Placebo application

Other: Purified Water

Interventions

Terbinafine Hydrochloride DRUG

4% w/w Terbinafine Hydrochloride Gel

Group A -Terbinafine HCl; Group B - Terbinafine HCl; Group C - Terbinafine HCl; Group D Terbinafine HCl; Group E

Purified Water OTHER

Purified Water

Group F - Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- • 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®).

You may not qualify if:

• \- • 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.

Sponsors & Collaborators

• Nitric BioTherapeutics, Inc: lead

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

International Clinical Research, LLC

Sanford, Florida, 32771, United States

Location

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, 30078, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Temple University Schoool of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Endeavor Clinical Trials, PA

San Antonio, Texas, 78229, United States

Location

Mediprobe Research, Inc

London, Ontario, N5X 2P1, Canada

Location

Lynderm Research, Inc

Markham, Ontario, L3P 1A8, Canada

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2012
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

CA (2); US (7)