An Unblinded Clinical Trial to Evaluate the Deposition of Terbinafine in the Nail Bed After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail

Nitric BioTherapeutics, Inc1 个研究点分布在 1 个国家目标入组 25 人开始时间: 2011年12月最近更新: 2012年10月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 25
试验地点: 1
主要终点: Level of terbinafine in the nail bed (ng/mg)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine how much terbinafine is delivered to the nail bed after treatment with a number of modifications to a previously studied method for iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small electric charge to deliver drug across skin and nails.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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
•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
•Topical antifungals other than terbinafine can be used on the body other than the feet after Day 0.

排除标准

•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