Overview

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

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Nitric BioTherapeutics, Inc
Treatments:
Terbinafine
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.