Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04940520 |
| Other study ID # |
Onicomicose |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Universidade do Vale do Sapucai |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
