Alpha-bisabolol for Onychomycosis Treatment

Universidade do Vale do Sapucai

Status and phase: Completed; Phase 1

Conditions: Onychomycosis

Treatments: Biological: Alpha bisabolol product; Combination Product: Alpha bisabolol product and laser; Biological: Drug recommended by the Brazilian Society of Dermatology

Study type: Interventional

Funder types: Other

Identifiers

NCT04940520

Onicomicose

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control group

Active Comparator group

Description:

Group A: control group, drug recommended by the Brazilian Society of Dermatology

Treatment:

Biological: Drug recommended by the Brazilian Society of Dermatology

Alpha-bisabolol and laser

Active Comparator group

Description:

Group B: alpha bisabolol-based product associated with low-level laser therapy

Treatment:

Combination Product: Alpha bisabolol product and laser

Alpha bisabolol

Active Comparator group

Description:

Group C: alpha bisabolol based product

Treatment:

Biological: Alpha bisabolol product