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
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring Onychomycosis, Phytotherapy, Laser Therapy, Plant Oils
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.
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
NCT ID
NCT04940520
First Posted
June 17, 2021
Last Updated
June 25, 2021
Sponsor
Universidade do Vale do Sapucai
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
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