Clinical trial NCT04940520: Alpha-bisabolol for Onychomycosis Treatment
Official title: Alpha-bisabolol for Onychomycosis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Onychomycosis
Keywords: Onychomycosis
Phytotherapy
Laser Therapy
Plant Oils
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Volunteers with onychomycosis,
* aged over 18 years.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Injury area analysis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Vale do Sapucaí University
state: Minas Gerais
Study officials:
affiliation: Vale do Sapucaí University
name: Adriana R dos Anjos Mendonça, PhD
role: PRINCIPAL_INVESTIGATOR
References: