Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nitric BioTherapeutics, Inc
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Positive KOH
25-75% involvement of the visible nail.
Nail plate must be \< 3 mm thick.
Must have signed informed consent.
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 Day 28.
Female subjects of childbearing potential must agree to take measures to avoid pregnancy until the day after Day 28
Must agree to avoid the use of oral antifungals or topical terbinafine anywhere on the body until the day after Day 28. Topical antifungals other than terbinafine can be used on the body other than the feet after Day 0.
You may not be if
Presence of proximal subungual onychomycosis or white superficial onychomycosis
Fungal involvement of a majority of the lunula
Subjects with psoriasis, eczema, or other abnormalities that could result in a clinically abnormal nail
Presence of dermatophytoma or onychomycotic spikes or exclusively lateral groove involvement
Traumatized or dystrophic target great toenail.
Known diabetics
Subjects with peripheral vascular disease
Subjects who are immunosuppressed (chronic corticosteroid therapy, 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 systemic corticosteroids within 30 days preceding Day 0
Use of topical antifungals on the feet in the preceding 30 days of Day 0 through Day 28
Use of topical terbinafine in the 30 days prior to treatment through Day 28
Use of systemic antifungals in the preceding 120 days of Day 0 through Day 28
Use of any investigational drug(s) within 30 days (120 days for systemic antifungals) preceding Day 0 through Day 28
Has previously participated in this study
Is pregnant or is a nursing mother
Women of of child bearing potential who are not using an adequate form of contraception (or abstinence)
Subjects with pacemakers/automatic implantable cardioverter/defibrillators
Subjects with an implantable electronic device.
Subjects with a bleeding disorder or who are using warfarin or any other blood coagulation modulator including aspirin in the 14 days prior to treatment through Day 28
Clareo Health | Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail
