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

Nitric BioTherapeutics

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Other: Purified Water; Drug: Terbinafine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01080079

CTP-9

Details and patient eligibility

About

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

Enrollment: 168 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 6 patient groups, including a placebo group

Group A -Terbinafine HCl

Active Comparator group

Description:

Terbinafine HCl

Treatment:

Drug: Terbinafine Hydrochloride

Group B - Terbinafine HCl

Active Comparator group

Description:

Terbinafine HCl

Treatment:

Drug: Terbinafine Hydrochloride

Group C - Terbinafine HCl

Active Comparator group

Description:

Terbinafine HCl

Treatment:

Drug: Terbinafine Hydrochloride

Group D Terbinafine HCl

Active Comparator group

Description:

Terbinafine HCl

Treatment:

Drug: Terbinafine Hydrochloride

Group E

Active Comparator group

Description:

Terbinafine HCl

Treatment:

Drug: Terbinafine Hydrochloride

Group F - Placebo

Placebo Comparator group

Description:

Placebo application

Treatment:

Other: Purified Water