A Subject Blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail

Nitric BioTherapeutics, Inc9 个研究点分布在 2 个国家目标入组 168 人开始时间: 2010年5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: 168
试验地点: 9
主要终点: Clinical and Microbiological Improvement in nails vs placebo

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 if the iontophoretic application of terbinafine gel is safe and effective for teh treatment of distal subungual onychomycosis

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: Single (Participant)

入排标准

年龄范围: 18 Years 至 69 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•• 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®).

排除标准

•• 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.