Onychomycosis of Toenail
Conditions
Brief 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. 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.
Interventions
DEVICE1064 nm Nd:YAG-laser therapy
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.
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fungal infection status in nail clippings measured by microscopy after laser treatment. | 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. | 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. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fungal infection status in nail clippings measured by PCR after laser treatment. | Approximately 10 minutes after treatment | The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR after therapy. |
| Nail clippings temperatures | Approximately 2 seconds after end of treatment. | Nail clippings temperature measured at the end of treatment |
| Fungal infection status in nail clippings measured by PCR before laser treatment. | Approximately 10 minutes before treatment | The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR before therapy. |
Countries
Denmark
Outcome results
None listed