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临床试验/NCT04940520
NCT04940520已完成1 期

Alpha-bisabolol for Onychomycosis Treatment

Universidade do Vale do Sapucai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriana Rodrigues dos Anjos Mendonça

Principal Investigator

Universidade do Vale do Sapucai

研究点 (1)

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