Alpha-bisabolol for Onychomycosis Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Injury area analysis
研究概览
简要总结
Clinical, interventional, longitudinal study with random sampling. 60 patients will be divided into three groups, group A: control group, drug recommended by the Brazilian Society of Dermatology, group B: alpha bisabolol-based product associated with low-level laser therapy, and group C: alpha bisabolol based product. The topical application will be performed twice a day, while the laser application and photographs of the lesions, every 15 days. Areas of the lesions will be compared.
详细描述
Introduction
Onychomycosis is an infection caused by fungi that feed on keratin, a protein that makes up most of the nails. In patients with diabetes mellitus and onychomycosis, the risk of foot complications is a concern, especially for those who do not perform the practice of self-care of the skin, nails and feet in general correctly, which can trigger an important tissue damage that culminates in limb amputation. One of the alternatives for the treatment are herbal medicines. The application of alpha-bisabolol in the pharmaceutical sector is related to its anti-inflammatory, antispasmodic, antiallergic, drug permeation and deworming properties, having an important action in the morphology of dermatophytic fungal cells. Objectives: Develop and evaluate a pharmaceutical formula with alpha-bisololol for the treatment of onychomycosis. Methods: Clinical, interventional, longitudinal study with random sampling. The study will be held at the Sthomatherapy Clinic of the Nursing Care and Teaching Center at the Samuel Libânio Hospital and at the DermatoCare Clinic Stomatherapy and Podiatry Clinic, Pouso Alegre, MG. 60 patients with onychomycosis will participate in this study, which will be divided into three groups, group A: control group, drug recommended by the Brazilian Society of Dermatology, group B: alpha bisabolol-based product associated with low-level laser therapy, and group C: alpha bisabolol based product. The topical application will be performed twice a day, while the laser application and photographs of the lesions, every 15 days.
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 (Outcomes Assessor)
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
- •Volunteers with onychomycosis,
- •aged over 18 years.
排除标准
- •Volunteers have a known allergic process to topical treatment, and those who present an allergic reaction to alpha bisabolol
- •patients with a history of neoplasm in a location close to the nail plate, and patients with psoriasis.
- •Volunteers who withdraw their consent at any time during the research, and those who present an allergic reaction to alpha bisabolol
- •Pregnant women.
研究组 & 干预措施
Control group
Group A: control group, drug recommended by the Brazilian Society of Dermatology
干预措施: Drug recommended by the Brazilian Society of Dermatology (Biological)
Alpha-bisabolol and laser
Group B: alpha bisabolol-based product associated with low-level laser therapy
干预措施: Alpha bisabolol product and laser (Combination Product)
Alpha bisabolol
Group C: alpha bisabolol based product
干预措施: Alpha bisabolol product (Biological)
结局指标
主要结局
Injury area analysis
时间窗: 2 months
All participants will have their nails photographed every 15 days for treatment control and evolution. Theses areas will be compared using the Image J program.
次要结局
未报告次要终点
研究者
Adriana Rodrigues dos Anjos Mendonça
Principal Investigator
Universidade do Vale do Sapucai
