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Alpha-bisabolol for Onychomycosis Treatment

NCT ID: NCT04940520

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-05-01

Brief Summary

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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

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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.

Conditions

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Onychomycosis

Keywords

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Onychomycosis Phytotherapy Laser Therapy Plant Oils

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Drug recommended by the Brazilian Society of Dermatology

Intervention Type BIOLOGICAL

Using a drug recommended by the Brazilian Society of Dermatology, twice a day.

Alpha-bisabolol and laser

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

Group Type ACTIVE_COMPARATOR

Alpha bisabolol product and laser

Intervention Type COMBINATION_PRODUCT

Using alpha bisabolol-based product associated with low-level laser therapy. Alpha bisabolol-based product will be used twice a day, and laser therapy used once every fortnight.

Alpha bisabolol

Group C: alpha bisabolol based product

Group Type ACTIVE_COMPARATOR

Alpha bisabolol product

Intervention Type BIOLOGICAL

Using alpha bisabolol-based product twice a day

Interventions

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Drug recommended by the Brazilian Society of Dermatology

Using a drug recommended by the Brazilian Society of Dermatology, twice a day.

Intervention Type BIOLOGICAL

Alpha bisabolol product and laser

Using alpha bisabolol-based product associated with low-level laser therapy. Alpha bisabolol-based product will be used twice a day, and laser therapy used once every fortnight.

Intervention Type COMBINATION_PRODUCT

Alpha bisabolol product

Using alpha bisabolol-based product twice a day

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role lead

Responsible Party

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Adriana Rodrigues dos Anjos Mendonça

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana R dos Anjos Mendonça, PhD

Role: PRINCIPAL_INVESTIGATOR

Vale do Sapucaí University

Locations

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Vale do Sapucaí University

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Onicomicose

Identifier Type: -

Identifier Source: org_study_id