OnychomycosisPhase 2NCT01528813
Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis
A Phase 2 study testing Er:YAG laser + amorolfine lacquer and Amorolfine lacquer in people with Onychomycosis, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
The study aims to investigate the effectiveness of a single application of Er:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Er:YAG laser + amorolfine lacquer and Amorolfine lacquer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 2
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 19-60 year-old
- preserved cognitive status
- direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds
Who cannot join
- diabetes type 1 or 2; peripheral vascular disease
- having undergone any treatment in the last 6 months
- peripheral nerve disorders (e.g. peripheral neuropathy, Hansen's disease, etc)
- willing to paint nail during the study
- high blood pressure
- use of any immunosuppressive drugs; congenital or acquired immunodeficiency
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University Hospital of Brasilia
Brasília, Federal District, 70910-900
Orlando O Morais, M.D., +55(61)99162339, orlando.unb@gmail.com
Orlando O Morais, M.D.
About this study
Official title: AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE
The study aims to investigate the effectiveness of a single application of Er:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). The patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.
Read the detailed description
This is a trial study involving 30 subjects with onychomycosis of hands or feet. The patient must have at least 2 injured nails as each affected nail will receive a different treatment - self-controlled study design.
Therefore, each nail out of two from a single patient will be randomized into the following study arms:
Group A of nails - will receive only weekly application of amorolfine lacquer for a total of 6 months.
Group B of nails - will receive a single application of Er:YAG laser followed by weekly application of amorolfine lacquer for a total of 6 months.
At the end of 6 months the data from both groups, A and B, regarding *clinical cure, *mycological cure and *extent of damage to the nail plates will be analyzed using specific tests.
- Conditions
- Onychomycosis
- Being tested
- Er:YAG laser + amorolfine lacquer, Amorolfine lacquer
- Keywords
- Erbium-doped yttrium aluminium garnet laser, Er:YAG, Amorolfine lacquer, Dermatophytes, Subungual distal lateral onychomycosis, Drug delivery
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG laser + amorolfine lacquerDevice
Also called Loceryl, Er:YAG laser
To each compromised ungual unit randomly assigned to this group it will be applied a single session of Er:YAG laser to the ungual lamina in the beginning of study. Onwards, amorolfine lacquer will be applied weekly for a period of 06 months.
Amorolfine lacquerDrug
Also called Loceryl
To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG + amorolfine lacquer | Active comparator | 30 ungual units affected by onychomycosis due to dermatophytes Receives: Device: Er:YAG laser + amorolfine lacquer |
| Amorolfine lacquer | Placebo comparator | 30 ungual units affected by onychomycosis due to dermatophytes Receives: Drug: Amorolfine lacquer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of nail plate damage
At the beginning and after 6 months of treatment both the group, A and B, will have the length from nail cuticle to the closest point of damage to the nail plate measured by a millimeter scale. It will later be accessed to determine the clearance rate of the nail plate achieved with each treatment
Measured: 6 months
Secondary outcomes (2)
Mycological cure
After 6 months of treatment both the group, A and B, will be accessed by direct mycological examination and culture to evaluate mycological cure
Measured: 6 months
Clinical cure
After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izelda Maria Carvalho Costa, Brasilia University Hospital
- Investigators
- Orlando O Morais, M.D., Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528813
- Sponsor's protocol ID
- HUB-UnB OnychoLASER
- Status last verified
- Aug 2013
- First submitted
- 5 Feb 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Morais OO, Costa IM, Gomes CM, Shinzato DH, Ayres GM, Cardoso RM. The use of the Er:YAG 2940nm laser associated with amorolfine lacquer in the treatment of onychomycosis. An Bras Dermatol. 2013 Sep-Oct;88(5):847-9. doi: 10.1590/abd1806-4841.20131932.
PubMed 24173203
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE
- ClinicalTrials.gov ID
- NCT01528813
- Acronym / sponsor ID
- HUB-UnB OnychoLASER
- Conditions
- Onychomycosis
- Keywords
- Erbium-doped yttrium aluminium garnet laser, Er:YAG, Amorolfine lacquer, Dermatophytes, Subungual distal lateral onychomycosis, Drug delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Feb 2012 (estimated)
- 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.
The study aims to investigate the effectiveness of a single application of Er:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). The patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.
Detailed description
This is a trial study involving 30 subjects with onychomycosis of hands or feet. The patient must have at least 2 injured nails as each affected nail will receive a different treatment - self-controlled study design.
Therefore, each nail out of two from a single patient will be randomized into the following study arms:
Group A of nails - will receive only weekly application of amorolfine lacquer for a total of 6 months.
Group B of nails - will receive a single application of Er:YAG laser followed by weekly application of amorolfine lacquer for a total of 6 months.
At the end of 6 months the data from both groups, A and B, regarding *clinical cure, *mycological cure and *extent of damage to the nail plates will be analyzed using specific tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Er:YAG + amorolfine lacquer | Active comparator | Device: Er:YAG laser + amorolfine lacquer30 ungual units affected by onychomycosis due to dermatophytes |
| Amorolfine lacquer | Placebo comparator | Drug: Amorolfine lacquer30 ungual units affected by onychomycosis due to dermatophytes |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 19-60 year-old
- preserved cognitive status
- direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds
Key exclusion criteria (6 listed)
- diabetes type 1 or 2; peripheral vascular disease
- having undergone any treatment in the last 6 months
- peripheral nerve disorders (e.g. peripheral neuropathy, Hansen's disease, etc)
- willing to paint nail during the study
- high blood pressure
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 |
|---|---|---|
| Er:YAG laser + amorolfine lacquerAlso: Loceryl, Er:YAG laserTo each compromised ungual unit randomly assigned to this group it will be applied a single session of Er:YAG laser to the ungual lamina in the beginning of study. Onwards, amorolfine lacquer will be applied weekly for a period of 06 months. | Device | Er:YAG + amorolfine lacquer |
| Amorolfine lacquerAlso: LocerylTo each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months. | Drug | Amorolfine lacquer |
Primary outcome
Extent of nail plate damage
Time frame: 6 months
At the beginning and after 6 months of treatment both the group, A and B, will have the length from nail cuticle to the closest point of damage to the nail plate measured by a millimeter scale. It will later be accessed to determine the clearance rate of the nail plate achieved with each treatment
2 secondary outcomes
Mycological cure
Time frame: 6 months
Clinical cure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 24173203Morais OO, Costa IM, Gomes CM, Shinzato DH, Ayres GM, Cardoso RM. The use of the Er:YAG 2940nm laser associated with amorolfine lacquer in the treatment of onychomycosis. An Bras Dermatol. 2013 Sep-Oct;88(5):847-9. doi: 10.1590/abd1806-4841.20131932.
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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.
Orlando O Morais, M.D. principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Er:YAG laser + amorolfine lacquer and Amorolfine lacquer in people with Onychomycosis, run by Brasilia University Hospital 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orlando O Morais, Investigator (+55(61)9916-2339, orlando.unb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of nail plate damage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528813, which also lists 1 linked publication.
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 7 Aug 2013.