Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will
be treated for 48 weeks with lacquer application to at least one affected great toenail. All
subjects will receive treatment with EcoNail™ lacquer.
Inclusion Criteria:
- Subjects who are men and women greater than or equal to 18 years of age and less than
or equal to 65 years of age.
- Female subjects who are post-menopausal (amenorrheic for at least 1 year), surgically
sterile, have a partner with a vasectomy, or routinely using an acceptable means of
contraception (acceptable methods may include hormonal contraceptives, intrauterine
device, spermicide and barrier, abstinence and partner/spouse sterility).
- Subjects who have mycologically confirmed distal subungual onychomycosis of at least
one or both great toenails ("target toenails"), defined as a positive result by
office-based KOH preparation (± Chlorazol B) and by laboratory culture demonstrating
one of more of the following organisms: T. rubrum, T. mentagrophytes, T. tonsurans
and/or E. floccosum
- Subjects who have target toenail showing 20-65% (+/- 2%) involvement as judged by the
clinical investigator.
- Subjects who have target toenail showing great than or equal to 3 mm distal
involvement as judged by the clinical investigator.
- Subjects who have target toenail showing great than or equal to 2 mm proximal clear
nail at the cuticle.
- Subjects must agree not to apply other nail polish or related products to the affected
nails for the duration of the study.
- Subjects must refrain from filing, clipping, or otherwise disturbing the treated
nail(s) for the duration of the study [NOTE: Clinic personnel will debride the
affected nails during monthly visits. Subjects should not engage in these activities
at home during the course of the study.]
- Subjects must have the ability to understand the nature of the study and any hazards
of participating in it and the willingness to communicate satisfactorily with the
investigator and staff and to participate in, and comply with the requirements of the
entire study.
- Subjects must be able to read and sign the study Informed Consent form and comply with
the requirements outlined in the informed consent form.
Exclusion Criteria:
- Subjects with < 20% or > 65% (+/- 2%) involvement of the target toenail.
- Subjects with great than or equal to 4 mm thickness of the target toenail.
- Subjects with totally dystrophic great toe.
- Subjects with great toenails which show white superficial or proximal subungual
onychomycosis, or a "spike" of onychomycosis extending to the cuticle.
- Subjects whose nail cultures grow Candida species as the only pathogen.
- Subjects who have reported treatment with a topical anti-fungal agent for
onychomycosis during the four weeks prior to screening for this study.
- Subjects who have been treated with a systemic anti-fungal agent during the three
months prior to screening for this study.
- Subjects with any other nail abnormality or dermatological condition, including (but
not limited to) psoriasis and lichen planus, that could prevent obtaining a
normal-appearing toenail if complete cure was achieved or could otherwise interfere
with required study assessments.
- Subjects with a history of organ transplantation, Human Immunodeficiency Virus (HIV)
seropositivity or other historical or clinical evidence of an immunocompromised
state.
- Subjects with a history of uncontrolled insulin-dependent diabetes mellitus.
- Subjects with a history of diabetic peripheral neuropathy.
- Subjects with a history of clinically significant lower extremity peripheral occlusive
vascular disease.
- Subjects with a presence of plantar (moccasin) tinea pedis.
- Subjects with a history of hypersensitivity or allergic reactions on the skin or
nails, including reactions to nail polish and/or nail polish remover.
- Subjects known to have an allergy to econazole, ethanol, Eudragit, or SEPA.
- Female subjects who are pregnant or lactating.
- Subjects with clinically relevant abnormal history, physical findings, or laboratory
values at the screening assessment that could interfere with the objectives or the
safety of the volunteer.
- Subjects who have a condition or abnormality that in the investigator's opinion may
interfere with the assessments, conduct of the study, may affect the subject's safety,
or is otherwise unsuitable for enrollment.
- Subjects who are currently participating or, within the previous 30 days, have
participated in another investigational drug study.
