Use of Topical Essential Oil Compound to Treat Toe Nail Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Subject Perceived Improvement in overall toenail infection
研究概览
简要总结
Patients with documented onychomycosis of one or more toe nails will be treated with a daily application of a topical lacquer containing several essential oils.
详细描述
The topical lacquer contains the following components:
Active ingredients:
Hydroxypropyl Chitosan OLEOZON(r) - natural, ozonized sunflower oil. Vitamin E Tea Tree Oil Cannabidiol
Vehicle:
Nanoparticle medium chain triglyceride oil
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinician observation consistent with probable onychomycosis of one or more toenails.
- •Positive polymerase chain reaction (PCR) for fungal infection or Positive Periodic Acid Schiff, Biopsy, KOH or Culture for fungal infection -
排除标准
- •Unwlling to discontinue current anti-fungal medication, oral or topical
结局指标
主要结局
Subject Perceived Improvement in overall toenail infection
时间窗: 12 weeks
Subject's personal perception of improvement of all infected toenails using the OnyCOE-t questionnaire for patient reported outcomes for toenail onychomycosis at baseline, 2,5 ,9 and 12 weeks of treatment.
Change in Thickness of the Hyponychium Fungal Infection
时间窗: 12 weeks
Objective change in the thickness of the hyponychium of the most infected nailplate. The hyponycium will be measured with a micometer thickness guage in micrometer gradations at baseline, 2,5,9 and 12 weeks.
次要结局
未报告次要终点
研究者
Gregory L Smith, MD, MPH
Principal Investigaor
Medical Life Care Planners, LLC