Clinical trial NCT05260450: Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
Official title: Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis of Toenail
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fungal infection status in nail clippings measured by microscopy after laser treatment.
timeFrame: Approximately 10 minutes after treatment
measure: Fungal infection status in nail clippings measured by culture after laser treatment.
timeFrame: Approximately 10 minutes after treatment
measure: Fungal infection status in nail clippings measured by microscopy before laser treatment.
timeFrame: Approximately 10 minutes before treatment
measure: Fungal infection status in nail clippings measured by culture before laser treatment.
timeFrame: Approximately 10 minutes before treatment
Secondary outcomes:
measure: Fungal infection status in nail clippings measured by PCR before laser treatment.
timeFrame: Approximately 10 minutes before treatment
measure: Fungal infection status in nail clippings measured by PCR after laser treatment.
timeFrame: Approximately 10 minutes after treatment
measure: Nail clippings temperatures
timeFrame: Approximately 2 seconds after end of treatment.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Nordjylland
Study officials:
References: