OnychomycosisPhase 1NCT04940520
Alpha-bisabolol for Onychomycosis Treatment
A Phase 1 study testing Drug recommended by the Brazilian Society of Dermatology, Alpha bisabolol product and laser and Alpha bisabolol product in people with Onychomycosis, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Drug recommended by the Brazilian Society of Dermatology, Alpha bisabolol product and laser and Alpha bisabolol product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2020to 1 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers with onychomycosis,
- aged over 18 years.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Onychomycosis
- Being tested
- Drug recommended by the Brazilian Society of Dermatology, Alpha bisabolol product and laser, Alpha bisabolol product
- Keywords
- Onychomycosis, Phytotherapy, Laser Therapy, Plant Oils
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug recommended by the Brazilian Society of DermatologyBiological
Using a drug recommended by the Brazilian Society of Dermatology, twice a day.
Alpha bisabolol product and laserCombination 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 productBiological
Using alpha bisabolol-based product twice a day
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Group A: control group, drug recommended by the Brazilian Society of Dermatology Receives: 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 Receives: Combination Product: Alpha bisabolol product and laser |
| Alpha bisabolol | Active comparator | Group C: alpha bisabolol based product Receives: Biological: Alpha bisabolol product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jun 2020
- Primary completion30 Nov 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Rodrigues dos Anjos Mendonça, Universidade do Vale do Sapucai
- Investigators
- Adriana R dos Anjos Mendonça, PhD, Principal investigator, Vale do Sapucaí University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940520
- Sponsor's protocol ID
- Onicomicose
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-bisabolol for Onychomycosis Treatment
- ClinicalTrials.gov ID
- NCT04940520
- Acronym / sponsor ID
- Onicomicose
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Phytotherapy, Laser Therapy, Plant Oils
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Biological: Drug recommended by the Brazilian Society of DermatologyGroup A: control group, drug recommended by the Brazilian Society of Dermatology |
| Alpha-bisabolol and laser | Active comparator | Combination Product: Alpha bisabolol product and laserGroup B: alpha bisabolol-based product associated with low-level laser therapy |
| Alpha bisabolol | Active comparator | Biological: Alpha bisabolol productGroup C: alpha bisabolol based product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteers with onychomycosis,
- aged over 18 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug recommended by the Brazilian Society of DermatologyUsing a drug recommended by the Brazilian Society of Dermatology, twice a day. | Biological | Control group |
| Alpha bisabolol product and laserUsing 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. | Combination product | Alpha-bisabolol and laser |
| Alpha bisabolol productUsing alpha bisabolol-based product twice a day | Biological | Alpha bisabolol |
Primary outcome
Injury area analysis
Time frame: 2 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana R dos Anjos Mendonça, PhD principal investigator
Vale do Sapucaí University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug recommended by the Brazilian Society of Dermatology, Alpha bisabolol product and laser and Alpha bisabolol product in people with Onychomycosis, run by Universidade do Vale do Sapucai at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury area analysis (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.