Alpha-bisabolol for Onychomycosis Treatment

NCT04940520 | Completed Phase 1 DMC

• 1 other identifier: Onicomicose
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis

Keywords

Onychomycosis; Phytotherapy; Laser Therapy; Plant Oils

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Biological: Drug recommended by the Brazilian Society of Dermatology

Alpha-bisabolol and laser

ACTIVE COMPARATOR

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

Combination Product: Alpha bisabolol product and laser

Alpha bisabolol

ACTIVE COMPARATOR

Group C: alpha bisabolol based product

Biological: Alpha bisabolol product

Interventions

Drug recommended by the Brazilian Society of Dermatology BIOLOGICAL

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

Control group

Alpha bisabolol product and laser 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 and laser

Alpha bisabolol product BIOLOGICAL

Using alpha bisabolol-based product twice a day

Alpha bisabolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers with onychomycosis,
• aged over 18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Vale do Sapucaí University

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Adriana R dos Anjos Mendonça, PhD

  Vale do Sapucaí University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: June 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: May 1, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)