search
Back to results

Alpha-bisabolol for Onychomycosis Treatment

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Drug recommended by the Brazilian Society of Dermatology
Alpha bisabolol product and laser
Alpha bisabolol product
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Onychomycosis, Phytotherapy, Laser Therapy, Plant Oils

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Vale do Sapucaí University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Alpha-bisabolol and laser

Alpha bisabolol

Arm Description

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

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

Group C: alpha bisabolol based product

Outcomes

Primary Outcome Measures

Injury area analysis
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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2021
Last Updated
June 25, 2021
Sponsor
Universidade do Vale do Sapucai
search

1. Study Identification

Unique Protocol Identification Number
NCT04940520
Brief Title
Alpha-bisabolol for Onychomycosis Treatment
Official Title
Alpha-bisabolol for Onychomycosis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Onychomycosis, Phytotherapy, Laser Therapy, Plant Oils

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Group A: control group, drug recommended by the Brazilian Society of Dermatology
Arm Title
Alpha-bisabolol and laser
Arm Type
Active Comparator
Arm Description
Group B: alpha bisabolol-based product associated with low-level laser therapy
Arm Title
Alpha bisabolol
Arm Type
Active Comparator
Arm Description
Group C: alpha bisabolol based product
Intervention Type
Biological
Intervention Name(s)
Drug recommended by the Brazilian Society of Dermatology
Intervention Description
Using a drug recommended by the Brazilian Society of Dermatology, twice a day.
Intervention Type
Combination Product
Intervention Name(s)
Alpha bisabolol product and laser
Intervention Description
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
Biological
Intervention Name(s)
Alpha bisabolol product
Intervention Description
Using alpha bisabolol-based product twice a day
Primary Outcome Measure Information:
Title
Injury area analysis
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana R dos Anjos Mendonça, PhD
Organizational Affiliation
Vale do Sapucaí University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vale do Sapucaí University
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37550-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alpha-bisabolol for Onychomycosis Treatment

We'll reach out to this number within 24 hrs