Onychomycosis of ToenailNCT05260450
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
A study testing 1064 nm Nd:YAG-laser therapy in people with Onychomycosis of Toenail, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This study aims to assess if laser treatment can cure fungal infection in toenails. Nail clippings from eligible subjects were obtained and randomised into two groups. All nail clippings were treated once with a 1064 nm Nd:YAG-laser. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- 1064 nm Nd:YAG-laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Oct 2021to 6 Dec 2021
- Phase
- Interventional
- 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
- Adult patient (>18 years)
- Clinical suspicion of fungal infection in at least one toenail
- Signed informed consent
- Sufficient nail material to perform two cultures and one nail clipping
Who cannot join
- Administration of oral antifungal medication in the last 12 months or topical antifungal medication in the last month
- Diabetes mellitus with associated peripheral artery disease (PAD) or neuropathy
- Under the influence of alcohol or illegal narcotics
- Unable to understand written and spoken Danish
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess if laser treatment can cure fungal infection in toenails.
Nail clippings from eligible subjects were obtained and randomised into two groups. All nail clippings were treated once with a 1064 nm Nd:YAG-laser. Before and after treatment, nail clippings were tested for fungal infection by microscopy and by culture.
Read the detailed description
This study was carried out as a randomised controlled trial (RCT) including two treatment groups subjected to two different laser treatments. A 1064 nm Nd:YAG-laser (Candela Medical, Ellipse Nordlys (Nd:YAG 1064), USA) was used for all treatments.
Potential subjects were recruited from general practitioners and skin clinics in North Jutland from August 24th, 2021, through December 2021.
All interventions and mycological tests for each subject were performed over the course of one day.
After subjects were included, toenails with a clinical suspicion of onychomycosis (OM) were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.
The nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.
Immediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy.
- Conditions
- Onychomycosis of Toenail
- Being tested
- 1064 nm Nd:YAG-laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064 nm Nd:YAG-laser therapyDevice
All interventions and mycological tests for each subject were performed over the course of one day.
After subjects were included, toenails with a clinical suspicion of OM were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.
The nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.
Immediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Long-pulsed group) | Experimental | Nail clippings allocated to group A received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 10 ms, spot size 3 mm, fluence 40-50 J/cm2, number of laser pulses 100 /cm2. Receives: Device: 1064 nm Nd:YAG-laser therapy |
| Group B (Short-pulsed group) | Active comparator | Nail clippings allocated to group B received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 0.3 ms, spot size 3 mm, fluence 40 J/cm2, number of laser pulses 100 /cm2. Receives: Device: 1064 nm Nd:YAG-laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fungal infection status in nail clippings measured by microscopy after laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy after therapy.
Measured: Approximately 10 minutes after treatment
Fungal infection status in nail clippings measured by culture after laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture after therapy.
Measured: Approximately 10 minutes after treatment
Fungal infection status in nail clippings measured by microscopy before laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy before therapy.
Measured: Approximately 10 minutes before treatment
Fungal infection status in nail clippings measured by culture before laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture before therapy.
Measured: Approximately 10 minutes before treatment
Secondary outcomes (3)
Fungal infection status in nail clippings measured by PCR before laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR before therapy.
Measured: Approximately 10 minutes before treatment
Fungal infection status in nail clippings measured by PCR after laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR after therapy.
Measured: Approximately 10 minutes after treatment
Nail clippings temperatures
Nail clippings temperature measured at the end of treatment
Measured: Approximately 2 seconds after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start4 Oct 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Bisp Sørensen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260450
- Sponsor's protocol ID
- 20210020
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
- ClinicalTrials.gov ID
- NCT05260450
- Acronym / sponsor ID
- 20210020
- Conditions
- Onychomycosis of Toenail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 2 Mar 2022 (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.
This study aims to assess if laser treatment can cure fungal infection in toenails.
Nail clippings from eligible subjects were obtained and randomised into two groups. All nail clippings were treated once with a 1064 nm Nd:YAG-laser. Before and after treatment, nail clippings were tested for fungal infection by microscopy and by culture.
Detailed description
This study was carried out as a randomised controlled trial (RCT) including two treatment groups subjected to two different laser treatments. A 1064 nm Nd:YAG-laser (Candela Medical, Ellipse Nordlys (Nd:YAG 1064), USA) was used for all treatments.
Potential subjects were recruited from general practitioners and skin clinics in North Jutland from August 24th, 2021, through December 2021.
All interventions and mycological tests for each subject were performed over the course of one day.
After subjects were included, toenails with a clinical suspicion of onychomycosis (OM) were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.
The nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.
Immediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Long-pulsed group) | Experimental | Device: 1064 nm Nd:YAG-laser therapyNail clippings allocated to group A received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 10 ms, spot size 3 mm, fluence 40-50 J/cm2, number of laser pulses 100 /cm2. |
| Group B (Short-pulsed group) | Active comparator | Device: 1064 nm Nd:YAG-laser therapyNail clippings allocated to group B received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 0.3 ms, spot size 3 mm, fluence 40 J/cm2, number of laser pulses 100 /cm2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (>18 years)
- Clinical suspicion of fungal infection in at least one toenail
- Signed informed consent
- Sufficient nail material to perform two cultures and one nail clipping
Key exclusion criteria (4 listed)
- Administration of oral antifungal medication in the last 12 months or topical antifungal medication in the last month
- Diabetes mellitus with associated peripheral artery disease (PAD) or neuropathy
- Under the influence of alcohol or illegal narcotics
- Unable to understand written and spoken Danish
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 |
|---|---|---|
| 1064 nm Nd:YAG-laser therapyAll interventions and mycological tests for each subject were performed over the course of one day. After subjects were included, toenails with a clinical suspicion of OM were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B. The nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once. Immediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy. | Device | Group A (Long-pulsed group), Group B (Short-pulsed group) |
Primary outcome
Fungal infection status in nail clippings measured by microscopy after laser treatment.
Time frame: Approximately 10 minutes after treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy after therapy.
Fungal infection status in nail clippings measured by culture after laser treatment.
Time frame: Approximately 10 minutes after treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture after therapy.
Fungal infection status in nail clippings measured by microscopy before laser treatment.
Time frame: Approximately 10 minutes before treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy before therapy.
Fungal infection status in nail clippings measured by culture before laser treatment.
Time frame: Approximately 10 minutes before treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture before therapy.
3 secondary outcomes
Fungal infection status in nail clippings measured by PCR before laser treatment.
Time frame: Approximately 10 minutes before treatment
Fungal infection status in nail clippings measured by PCR after laser treatment.
Time frame: Approximately 10 minutes after treatment
Nail clippings temperatures
Time frame: Approximately 2 seconds after end of treatment.
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 2 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1064 nm Nd:YAG-laser therapy in people with Onychomycosis of Toenail, run by Aalborg University Hospital at 1 site in Denmark.
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 4 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 2 Mar 2022. 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 Denmark. 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.
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?
Fungal infection status in nail clippings measured by microscopy after laser treatment. (time frame: Approximately 10 minutes after treatment). The study lists 4 primary outcomes in all. 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 2 Mar 2022.