Dr. Bill Antifungal Nail Gel Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diclofenac sodium serum levels
研究概览
简要总结
Study evaluates these take of diclofenac sodium when used in conjunction with miconazole and urea as a topical antifungal nail gel treatment for onychomycosis. All of the patient's will be treated with the active formula and blood levels of diclofenac sodium tested for as well as monitoring of hepatic and renal functions
详细描述
Tinea Unguium/onychomycosis is a ubiquitous health problem affecting ~3% of the adult population. It is associated with higher risk for other disease processes. Effective treatment for this disease has been lacking. Oral antifungal agents are associated with high incidence of recurrence of disease, hepatotoxicity, cytochrome P450 Pathway interference, non-compliance, side effects and cost. No effective long-term topical applications have been verified. Debridement of the damaged nail in combination with a broad-spectrum topical antifungal agent and an anti-inflammatory agent is a safe, inexpensive and easily formulated alternative to previous ineffective treatments. The rationale for debridement is simple in that the effectiveness of the topical antifungal is present only when it is in contact with the fungal agent, nail bed and involved diseased tissue. The associated inflammatory response associated with fungal infections is well-established. The only topical NSAID available in the United States is diclofenac sodium. The combination of miconazole, diclofenac sodium and urea has proven effective in this researcher's self-treatment of tinea unguium. Miconazole and diclofenac sodium are well studied and well-established pharmaceutical
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 21 years of age at Visit
- •Not pregnant.
- •Stage 3 or lower Chronic Renal Failure.
- •PT/INR < 1.3 and not on anti-thrombotic; AST, ALT, Total Bilirubin WNL.
- •Documentation of a diagnosis of tinea unguium as evidenced by one or more clinical features consistent with the onychomycosis and one or more of the following criteria: KOH prep of the nail scrapings or positive culture of the nail scrapings; culture of nail with growth of any of the following Dermatophytes, non-dermatophytes or yeast.
- •TABLE 1 Epidermophyton floccosum Trichophyton mentagrophytes Trichophyton rubrum Acremonium Alternaria species Aspergillus species Botryodiplodia theobromae Fusarium species Onycochola canadensis Pyrenochaeta unguis-hominis Scytalidium dimidiatum scopulariopsis species Scytalidium hyalimum Candida albicans
排除标准
- •Chronic renal failure, chronic liver disease, alcoholism, pregnant, breastfeeding, or unwilling to practice birth control during participation in the study if of childbearing age..
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Concomitant use of any prescribed medication that may be adversely affected by diclofenac sodium.
研究组 & 干预措施
Experimental
miconazole 3% & diclofenac sodium 1% & urea 40% in topical gel daily for 6 months.
干预措施: Antifungal Nail Gel Study (Drug)
结局指标
主要结局
Diclofenac sodium serum levels
时间窗: 12 hours
Peak Plasma Concentration (Cmax) diclofenac sodium 12 hours after 1st dose
次要结局
- Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application(3 months)
研究者
William N Handelman
Principal Investigator
Bay Area Medical